Transponders and sensors for implantable medical devices and methods of use thereof

ABSTRACT

Implantable transponders comprising no ferromagnetic parts for use in medical implants are disclosed herein. Such transponders may assist in preventing interference of transponders with medical imaging technologies. Such transponders may optionally be of a small size, and may assist in collecting and transmitting data and information regarding implanted medical devices. Methods of using such transponders, readers for detecting such transponders, and methods for using such readers are also described.

CROSS-REFERENCE TO RELATED APPLICATIONS

This disclosure claims priority to U.S. Provisional Application No.62/313,218, filed on Mar. 25, 2016, and U.S. Provisional Application No.62/293,052, filed on Feb. 9, 2016, each of which is incorporated byreference herein in its entirety.

FIELD OF DISCLOSURE

The present disclosure relates generally to transponder and sensorsystems for use with implantable medical devices, implants incorporatingsuch systems, and methods of use thereof.

BACKGROUND

Implantable medical devices may be implanted into patients for a varietyof reasons, including, for example, to improve the clinical condition ofa patient, to replace natural patient tissue, or for aesthetic purposes.In many cases, implantable medical devices are implanted in patientshaving severe, complex, or chronic medical conditions. For example,breast implants may be used in reconstructive surgeries followingmastectomies, e.g., after a cancer diagnosis, surgical removal of breasttissue, radiation therapy, and/or chemotherapy.

There are many situations in which implantable medical devices and thetissue in which they are implanted may need to be examined, monitored,identified, or further altered after implantation, either by invasive ornoninvasive means. For example, after implantation of a medical device,follow-up may be required to monitor healing, check for clinicalimprovement, and/or screen for development or reappearance of othermedical conditions in the vicinity of the medical device (e.g., thereappearance of cancerous tissue in a patient in remission). As afurther example, it may be advantageous to be able to identifycharacteristics of an implanted device, such as the device's model,size, shape, lot number, or other characteristics, without performing aninvasive procedure to visually inspect the device. As yet anotherexample, some implantable medical devices may require adjustment afterimplantation. For example, tissue expanders, such as those which may beused in patients undergoing breast augmentation or reconstructionsurgery, may be designed to be incrementally expanded over time.

Various technologies have been developed in order to improve the safetyand efficacy of breast implants and other implantable medical devices,in part to address some of the above concerns. Among these technologiesis the use and integration of transponders, such as radio-frequencyidentification (RFID) transponders, in implantable medical devices. Suchtransponders may be used, for example, to transmit information fromwithin a patient's body, such as information about a location of thedevice in the patient's body, or a location of a portion of the devicein the patient's body. As another example, such transponders may be usedto transmit information about an implanted device itself by way of,e.g., a serial number encoded on a chip in each transponder. Informationabout the implanted device may be useful for, e.g., determining whetherthe device is subject to any recalls, determining the materials in thedevice, and planning further surgeries. Information about implantablemedical devices may also be useful prior to implantation, such as totrack the devices from manufacturing, through storage, sale, transport,delivery to medical centers, and implantation in patients.Microtransponders, such as transponders which have a length of less thanthree centimeters and a width of less than a centimeter, may provide theadded advantage of being small enough for inclusion within implantablemedical devices without substantially affecting, e.g., the size, shape,feel, or function of those devices.

However, safety of implantable medical devices, and compatibility ofimplantable medical devices with continued patient care, are also aconcern. Transponders within implanted medical devices may interferewith the use of certain diagnostic, imaging, or other medical techniqueson patients having implants with such transponders. For example, inpatients requiring monitoring, examination, and/or screening afterimplantation of a medical device, it may be necessary for the device tobe compatible with the use of various scanning, imaging, and diagnostictechniques, such as magnetic resonance imaging (MM), radiography,ultrasound, tomography, etc. Transponders known in the art may, forexample, include ferromagnetic parts, which may interfere with, e.g., anMM performed on a patient having such a transponder in his or her body.Such interference may include, for example, the production of anartifact (e.g., a small imaging void) in imaging results taken of apatient. In such cases, the presence of the artifact in the imagingresult may be associated with an increased risk of missing a diagnosisof a patient's condition. For example, a medical professional may miss adiagnosis of recurring cancer due to the artifact obscuring a portion ofan MRI showing cancerous cells in the patient. As another example, arupture in an implant, which may normally be visible on MRI results, maybe obscured by an artifact in the results caused by a transponder. As aresult, MRI might not be a recommended imaging technique for such apatient, or MRI may need to be combined with another imaging techniquesuch as ultrasound, which may incur additional time and expenses on thepart of both the patient and medical professionals. As a furtherexample, transponders of a small size may be difficult for an externalreader to read after implants containing those transponders have beenimplanted in a patient. Alternately, a medical professional may prefernot to use an implant which includes a transponder that would produceunwanted artifacts in imaging results, and/or which may be difficult toread.

SUMMARY

The present disclosure includes implantable transponders comprisingfeatures that may provide for increased safety, compatibility withmedical imaging technology and other procedures, and decreased necessityfor invasive procedures. While portions of this disclosure refer tobreast implants and tissue expanders, the devices and methods disclosedherein may be used with other implantable medical devices, such as,e.g., other implants used in cosmetic and/or reconstruction procedures(e.g., gastric implants, gluteal implants, calf implants, testicularimplants, penile implants), pacemaker components (e.g., pacemakercovers) and other electro-stimulator implants, drug delivery ports,catheters, orthopedic implants, vascular and non-vascular stents, andother devices.

The present disclosure includes, for example, a transponder comprisingan electromagnetic coil and a core comprising a non-ferromagneticmaterial, wherein a length of the transponder is between about 5 mm andabout 30 mm, and a width of the transponder measures between about 2 mmand about 5 mm. The transponder may further comprise a capsule enclosingthe electromagnetic coil and the core. The transponder may also comprisean integrated circuit chip coupled to the coil. A diameter of the coilmay be greater than the width of the transponder. The core may comprisea core width and a core length, wherein the core length is greater thanthe core width, and wherein the coil is wrapped around the core suchthat the core length defines an inner diameter of the coil. Thetransponder may define a longitudinal axis along its length, and theelectromagnetic coil may include a wire wound along the direction of thelongitudinal axis. The transponder may also comprise an integratedcircuit chip coupled to each of two ends of the coil, a glass capsuleenclosing the electromagnetic coil, the integrated circuit chip, and aninner space between the glass capsule and the electromagnetic coil andintegrated circuit chip, and an adhesive material filling at least 30%of the inner space.

The present disclosure also includes, for example, a transpondercomprising a coil comprised of a wire, wherein a length of thetransponder measures between about 5 mm and about 30 mm, a width of thetransponder measures between about 2 mm and about 5 mm and is less thanthe length of the transponder, the transponder does not include aferromagnetic material, and the wire is wound around the length of thetransponder. The transponder may further comprise an integrated circuitchip coupled to the coil. The transponder may further comprise a capsuleenclosing the coil and the integrated circuit chip coupled to the coil.A diameter of the coil may be smaller than the length of the transponderand greater than the width of the transponder. The transponder may beconfigured to send and/or receive information within a range of fromabout 1 inch to about 5 feet. The wire may be an enameled copper wire.The transponder may be wound around a core comprising biocompatiblepoly-ether-ether-ketone (PEEK). The transponder may be cylindrical.

The present disclosure also includes, for example, a transpondercomprising an electromagnetic coil, an RFID chip, and a capsuleenclosing the electromagnetic coil and the RFID chip, wherein a lengthof the capsule is between about 5 mm and about 30 mm, a diameter of thecapsule perpendicular to the length is between about 2 mm and about 5mm, and the transponder does not include a ferromagnetic material. Thetransponder may define a longitudinal axis along its length, and theelectromagnetic coil may include a wire wound along the direction of thelongitudinal axis. The electromagnetic coil may be wound around a corecomprising biocompatible poly-ether-ether-ketone (PEEK). The core maycomprise two notched ends, and the electromagnetic coil may include awire wound around the core such that turns of the wire sit in each ofthe two notched ends. A longest diameter of the electromagnetic coil maybe longer than a height of the coil.

The present disclosure also includes, for example, an integrated portassembly, comprising a chamber configured to receive a fluid, a wirecoil, the coil sharing a central axis with the chamber, and a port domecovering an opening into the chamber. The wire coil may be anelectromagnetic coil. The wire coil may have two ends, wherein each endis coupled to an integrated circuit chip. The port dome may seal thechamber of the integrated port assembly. The port dome may also beself-sealing. The integrated port assembly may further comprise a walldefining a side of the chamber, the wall comprising at least one fluidexit hole. The integrated port assembly of claim may further comprise awire coil chamber housing the wire coil.

The present disclosure also includes, for example, an integrated portassembly, comprising a chamber configured to receive a fluid, thechamber having a fluid entry hole and a plurality of fluid exit holes, awire coil surrounding the chamber, and a patch covering the fluid entryhole of the chamber. The chamber may further include a needlepuncture-resistant surface opposite the fluid entry hole. The fluidentry hole may define a plane, and each of the plurality of fluid exitholes may define a plane perpendicular to the plane defined by the fluidentry hole. The wire coil may have two ends, wherein each end is coupledto an integrated circuit chip, and wherein the wire coil has an outerdiameter of between about 10 mm and about 50 mm. The integrated portassembly may further comprise at least four fluid exit holes. Theintegrated port assembly may further comprise a coil chamber housing thewire coil, wherein the coil chamber is impermeable to fluids. Theintegrated port assembly may be configured to be used with a breasttissue expander. The patch of the integrated port assembly may beconfigured to attach to the exterior of the breast tissue expander. Thepatch may also be self-sealing.

The present disclosure further includes, for example, an integrated portassembly comprising a casing defining a fluid injection chamberconfigured to receive a fluid via a fluid entry hole, a wire coil in acoil chamber, the coil chamber being isolated from the fluid injectionchamber, the coil having a central axis aligned with a center of thefluid injection chamber, and a port dome covering the fluid entry holeof the fluid injection chamber. The fluid injection chamber may comprisea plurality of fluid exit holes. The integrated port assembly mayfurther comprise an integrated circuit chip in the coil chamber, whereintwo ends of the wire coil are coupled to the integrated circuit chip.The coil may have an inner diameter of between about 15 mm and about 35mm.

The present disclosure further includes a method for broadcasting atransponder-specific signal, the method comprising: broadcasting, in arange of a transponder, radio frequency signals across a sweep offrequencies; evaluating a signal strength of each of received returnsignals from the transponder; determining a frequency of a broadcastedradio frequency signal corresponding to the received return signalhaving the greatest signal strength; and broadcasting a radio frequencysignal at the determined frequency. The method may further comprisereceiving, at a plurality of antennas, the return signals having aplurality of signal strengths. The method may further comprise:receiving a plurality of return signals having a plurality of signalstrengths; amplifying received return signals having signal strengthsbelow a threshold; and converting the amplified signals to digitalvalues. The step of evaluating the signal strength of the receivedreturn signals may comprise converting the received return signals todigital values. The sweep of frequencies may include frequencies withina range of from about 120 kHz to about 140 kHz. The range of thetransponder may be about 5 feet.

The present disclosure further includes a system for broadcasting atransponder-specific signal, the system comprising a microcontroller andat least one antenna, the microcontroller being programmed withinstructions for performing steps of a method, the method comprising:broadcasting, in the range of a transponder, radio frequency signalsacross a sweep of frequencies; evaluating a signal strength of each ofreceived return signals from the transponder; determining a frequency ofa broadcasted radio frequency signal corresponding to received returnsignal having the greatest signal strength; and broadcasting a radiofrequency signal at the determined frequency. The at least one antennamay comprise at least two antennas, and the method may further comprisereceiving, at the at least two antennas, a plurality of return signalshaving a plurality of signal strengths. The system may further comprisea logarithmic amplifier and an analog-to-digital converter, and themethod may further comprise: receiving, at the plurality of antennas, aplurality of return signals having a plurality of signal strengths;amplifying, using the logarithmic amplifier, received return signalshaving signal strengths below a threshold; and converting received andamplified signals to digital values using the analog-to-digitalconverter. The step of evaluating the strength of the received returnsignals may comprise converting the received return signals to digitalvalues. The sweep of frequencies may include frequencies within a rangeof from about 120 kHz to about 140 kHz. The range of the transponder maybe about 5 feet. The system may further comprise a clock generator and asignal driver for performing the step of broadcasting radio frequencysignals across a sweep of frequencies. The step of evaluating thestrength of received return signals from the transponder may compriseinstructing at least one analog-to-digital converter to convert receivedreturn signals into digital values, and comparing the digital values toone another.

The present disclosure further includes, for example, a method forbroadcasting a transponder-specific signal, the method comprising:broadcasting, in a range of a transponder, radio frequency signalsacross a sweep of frequencies using a signal driver and an antenna;receiving, using the antenna, return signals from the transponder;amplifying, using a logarithmic amplifier, return signals from thetransponder which are below a threshold; converting, using ananalog-to-digital converter, received return signals and amplifiedsignals into digital values; evaluating, using a microcontroller, thedigital values to determine the strongest return signal or signals;determining a frequency of a broadcasted radio frequency signalcorresponding to the strongest received return signal or signals fromthe transponder; and broadcasting, using the signal driver and antenna,a radio frequency signal at the determined frequency. The method mayfurther comprise receiving, at a pickup antenna, return signals from thetransponder which are below the threshold. The step of broadcasting, inthe range of a transponder, radio frequency signals across a sweep offrequencies may further comprise using a clock generator to determine atiming of the sweep of frequencies. The method may further comprisedisplaying, on an LED display, the determined frequency. The sweep offrequencies may include frequencies within a range of from about 120 kHzto about 140 kHz. The range of the transponder may be less than fivefeet.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate various examples and togetherwith the description, serve to explain the principles of the presentdisclosure. Any features of an embodiment or example described herein(e.g., device, method, etc.) may be combined with any other embodimentor example, and are encompassed by the present disclosure.

FIGS. 1A and 1B show an exemplary transponder, according to some aspectsof the present disclosure.

FIGS. 2A and 2B show another exemplary transponder, according to someaspects of the present disclosure.

FIGS. 3A-3C show an exemplary valve assembly, according to some aspectsof the present disclosure.

FIG. 4 shows another view of an exemplary valve assembly, according tosome aspects of the present disclosure.

FIGS. 5A-5C shows an exemplary integrated port valve assembly, accordingto some aspects of the present disclosure.

FIG. 6 shows another exemplary integrated port valve assembly, accordingto some aspects of the present disclosure.

FIGS. 7A and 7B show further views of the exemplary integrated portvalve assembly shown in FIG. 6, according to some aspects of the presentdisclosure.

FIG. 8 shows a schematic diagram of a platform reader, in accordancewith some aspects of the present disclosure.

FIG. 9 shows, in block diagram form, steps of an exemplary method ofbroadcasting a signal, according to further aspects of the presentdisclosure.

FIGS. 10A-10C show steps in an exemplary method of injecting fluid intoan implant, according to some aspects of the present disclosure.

FIG. 11 shows an exemplary implant shell according to some aspects ofthe present disclosure.

DETAILED DESCRIPTION

Aspects of the present disclosure are described in greater detail below.The terms and definitions as used and clarified herein are intended torepresent the meaning within the present disclosure. The terms anddefinitions provided herein control, if in conflict with terms and/ordefinitions incorporated by reference.

The singular forms “a,” “an,” and “the” include plural reference unlessthe context dictates otherwise. The terms “approximately” and “about”refer to being nearly the same as a referenced number or value. As usedherein, the terms “approximately” and “about” generally should beunderstood to encompass ±5% of a specified amount or value.

The present disclosure generally relates to medical implants, featuresof medical implants, transponders and sensors for use with suchimplants, and methods of using such transponders, sensors, and implants.Various aspects of the present disclosure may be used with and/orinclude one or more features disclosed in U.S. Provisional ApplicationNo. 62/313,218, entitled “Sensors for Implantable Medical Devices andMethods of Use Thereof,” filed on Mar. 25, 2016; U.S. ProvisionalApplication No. 62/293,052, entitled “Identification System IncludingTransponder With Non-Magnetic Core,” filed on Feb. 9, 2016; U.S.Provisional Application No. 62/318,402, entitled “Medical ImagingSystems, Devices, and Methods,” filed on Apr. 5, 2016; U.S. ProvisionalApplication No. 62/323,160, entitled “Minimally-Invasive Apparatus forthe Implantation of Medical Devices and Methods of Use Thereof,” filedon Apr. 15, 2016; U.S. Provisional Application No. 62/334,667, entitled“Implant Surface Technologies and Elements of Formation,” filed on May11, 2016; U.S. Application Publication No. 2015/0282926; U.S.Application Publication No. 2014/0081398; and/or U.S. ApplicationPublication No. 2014/0078013.

Aspects of the present disclosure may be useful for collecting and/oranalyzing data relevant to a patient, including, e.g., physiologicaldata and information about medical devices that may be implanted in thepatient. Devices, systems, and methods disclosed herein may also beuseful for locating and/or altering medical devices that may beimplanted in the patient, including, e.g., adjusting the size, shape,and/or position of medical devices that may be implanted in the patient.Such implantable medical devices may include, but are not limited to,breast implants, gluteal implants, tissue expanders, and other medicaldevices in the field of aesthetic or reconstructive surgery, as well asother types of medical devices configured for temporary or permanentimplantation inside a patient. Devices, systems, and methods disclosedherein may also be useful for overcoming challenges presented in theprior art, such as, e.g., artifacts produced by implanted transpondersin patient imaging results, and difficulty in reading transpondershaving weak signals.

As discussed herein, transponders, such as microtransponders, that aredesigned to avoid the creation of imaging artifacts (referred to hereinas “low-artifact transponders”), may be incorporated into implantablemedical devices to monitor the status of the medical devices over timeand/or to obtain certain types of patient data based on, among otherthings, the location of the transponders when implanted inside thepatient's body.

As also discussed herein, valve assemblies having locator coils, such asintegrated port assemblies designed for use in implants requiringperiodic addition of fluids such as, e.g., tissue expanders, may beincorporated into implantable medical devices to assist in noninvasivelocation of valve assemblies after the medical devices have beenimplanted inside the patient's body.

Readers configured to read multiple types of reading transponders andlocator coils, and methods of finding and broadcasting optimal signalsfor reading such transponders and/or locator coils, are also disclosedherein.

Various data analyses techniques, systems, and methods for use incombination with the transponders, coils, and readers disclosed hereinare also disclosed.

Transponders

The present disclosure includes low artifact transponders/chips that maycomprise materials and/or design configurations to minimize interferencethat may be observed from magnetic resonance imaging (MRI), fluoroscopic(X-ray) imaging, and/or ultrasound imaging. As previously noted, MRI,X-ray and ultrasound tests are frequently used for mammography andrelated tissue analysis to diagnose early signs of breast cancer, and toassess other unrelated heart and lung diseases. The transponders hereinmay be incorporated into breast implants and tissue expanders todecrease the amount of interference with diagnostic imaging.

Such transponders may be small in size, in order to avoid affecting thesize and shape of implants in which they are included. Such transpondersmay also include materials that are alternatives to ferromagneticmaterials, which can cause an imaging artifact under magnetic resonanceimaging. For example, the transponders herein may comprisenon-ferromagnetic materials, such as poly-ether-ether-ketone (PEEK),other plastics, ceramic, or silica (e.g., glass). Such transponders mayalso include configurations, such as antenna coil configurations, whichare designed to compensate for a lower antenna signal strengthassociated with small antenna coils having no ferromagnetic core.

FIGS. 1A and 1B depict, in schematic form, a top-down view (FIG. 1A) anda side view (FIG. 1B) of an exemplary transponder 100, which may embodyone or more aspects of the present disclosure. Transponder 100 mayinclude an assembly 101, which may include an antenna 102 and a chip110. Antenna 102 may include an antenna core 104 and an antenna coil106. Antenna 102 may be connected to a chip 110 via antenna coil ends108, which may be attached to bond pads 112 of chip 110. A capsule 114may enclose assembly 101 and an inner space 116, which may surroundassembly 101.

Transponder 100 may be configured, for example, to allow for collectionand/or transmission of data continuously, intermittently/periodically,and/or on-demand (e.g., prompted by a user). Transponder 100 may haveany of a variety of shapes and sizes suitable for inclusion in animplant. For example, transponder 100 may have a size and shape suitablefor inclusion in a breast implant, such as a silicone-filled breastimplant suitable for implantation in a patient during breastaugmentation or reconstruction surgery. In some embodiments, forexample, transponder 100 may have a size and shape suitable forinclusion in an implant without substantially altering the size, shape,or weight of the implant. In some embodiments, transponder 100 may besized and shaped for inclusion in a breast implant. In some embodiments,the overall size and shape of transponder 100 may be minimized so as topotentially reduce any effect of the transponder on the size, shape,look, feel, or implantation process of an implant in which transponder100 is installed. Minimizing the overall size and shape of transponder100 may also assist in avoiding transponder interference with patientdiagnostics, imaging procedures, and/or other medical procedures.Transponder 100 may also have an overall size and shape dictated in partby its components, as described in further detail below. For example,transponder 100 may have a long dimension, or length, determined in partby a size and shape of assembly 101, and in particular a size and shapeof antenna 102.

In some embodiments, the long dimension, or length, of transponder 100may measure between about 5 mm and about 30 mm, such as between about 5mm and about 10 mm, between about 8 mm and about 13 mm, between about 10mm and about 20 mm, between about 10 mm and about 15 mm, between about12 mm and about 18 mm, between about 15 mm and about 20 mm, betweenabout 15 mm and about 25 mm, between about 18 mm and about 26 mm, orbetween about 20 mm and about 30 mm. In some embodiments, transponder100 may have a long dimension measuring about 8 mm, about 10 mm, about13 mm, about 15 mm, about 18 mm, about 20 mm, about 23 mm, or about 25mm.

In some embodiments, transponder 100 may have a width w, or shortdimension perpendicular to the length (as seen in the top view oftransponder 100 in FIG. 1A), measuring between about 1 mm and about 20mm. For example, in some embodiments, transponder 100 may have a widthmeasuring between about 2 mm and about 8 mm, between about 2 mm andabout 5 mm, between about 2 mm and about 3 mm, between about 3 mm andabout 6 mm, between about 5 mm and about 10 mm, between about 7 mm andabout 12 mm, or between about 10 mm and about 15 mm. In someembodiments, transponder 100 may have a width, or short dimension,measuring about 1 mm, about 2 mm, about 3 mm, about 5 mm, or about 6 mm.

In some embodiments, transponder 100 may have a thickness, or shortdimension perpendicular to both the width w and length of transponder100, measuring between about 1 mm and about 20 mm. In some embodiments,for example, transponder 100 may have a thickness that is about the sameas the width w of transponder 100. In further embodiments, for example,transponder 100 may have a thickness that is larger or smaller than thatof width w of transponder 100.

In some embodiments, transponder 100 may be generally elongated inshape. For example, in some embodiments, transponder 100 may have alength which is more than twice as long as its width. Transponder 100may have a length of about 13 mm and a width of about 2 mm, or a lengthof about 13 mm and a width of about 2.8 mm. In further embodiments,transponder 100 may have a length of about 13 mm and a width of about2.2 mm. In further embodiments, transponder 100 may have a length ofabout 18 mm and a width of about 3 mm. An elongated shape may, forexample, allow for ease of insertion of transponder 100 into a medicalimplant using, for example, a syringe into which transponder 100 mayfit. An elongated shape may also, for example, be suitable for housingassembly 101 and, in particular, antenna 102, which are also elongatedin shape.

In some embodiments, for example, transponder 100 may be generallycylindrical in shape. In such embodiments, the width of transponder 100may be, for example, a diameter of the cylinder. In further embodiments,transponder 100 may be shaped as a rectangular prism, or any othershape. In some embodiments, transponder 100 may generally have few orrounded corners, in order to, e.g., reduce a risk of transponder 100damaging an implant into which transponder 100 is installed. In furtherembodiments, transponder 100 may be a generally flat square shape, ovoidshape, or any other shape suitable for accommodating the components oftransponder 100 and for placing the transponder 100 inside a medicaldevice.

Assembly 101 of transponder 100 may include, for example, an antenna 102and a chip 110, connected via antenna coil ends 108. Both antenna 102and chip 110 of assembly 101 are described further below.

Antenna 102 may include, for example, antenna core 104 and antenna coil106. In some embodiments, antenna coil 106 may be wound around antennacore 104. Antenna coil 106 may be made of a conductive,non-ferromagnetic material. In some embodiments, antenna coil 106 may bemade of a material that may be able to withstand high temperatures(e.g., temperatures ranging up to about 250 degrees centigrade) for upto about 10,000 hours. In some embodiments, antenna coil 106 may be madeof a metal wire, such as, e.g., copper wire or aluminum wire. In someembodiments, antenna coil 106 may be made of enameled wire, e.g., wirecoated in a polymer. Suitable polymers may include, e.g., polyvinylformal (Formvar), polyurethane, polyamide, polyester,polyester-polyimide, polyamide-polyimide (or amide-imide), andpolyimide. In some embodiments, antenna coil 106 may be made of enameledcopper wire, such as, e.g., Elektrisola enameled copper wire. In someembodiments, antenna coil 106 may be made of wire having a diameterranging from about 0.010 mm to about 0.500 mm. For example, antenna coil106 may be made of wire having a diameter of about 0.030 mm.

In some embodiments, antenna coil 106 may include tens to severalthousand turns (i.e., loops) of wire. For example, in some embodiments,antenna coil 106 may include between about 30 to about 1500 turns ofwire, such as between about 30 and about 100 turns, between about 100and about 200 turns, between about 100 and about 400 turns, betweenabout 100 and about 600 turns, between about 200 and about 500 turns,between about 300 and about 700 turns, between about 400 and about 600turns, between about 500 and about 800 turns, between about 600 andabout 900 turns, between about 800 and about 1000 turns, between about800 and about 1200 turns, between about 1000 and about 1500 turns, andbetween about 1100 and about 1500 turns.

As depicted in FIGS. 1A-2B, antenna coil 106 may be wound in alongitudinal direction along a transponder axis A-A such that it has alongitudinal turn diameter t. Turn diameter t may be greater than theheight of the coil h and/or the width of the coil x. Advantageously,this may, in some instances, allow for antenna coil 106 to, wheninduced, produce a stronger signal than an antenna coil which is wrappedsuch that it has a smaller longitudinal turn diameter t than its heighth and/or width x (e.g., wrapped in a direction transverse to axis A-A).In some embodiments, antenna coil 106 may have a turn diameter t rangingfrom about 5 mm to about 20 mm, such as, for example, from about 5 mm toabout 15 mm, from about 5 mm to about 12 mm, from about 5 mm to about 10mm, from about 5 mm to about 7 mm, from about 6 mm to about 8 mm, fromabout 7 mm to about 10 mm, from about 9 mm to about 13 mm, from about 10mm to about 15 mm, from about 12 mm to about 17 mm, from about 15 mm toabout 19 mm, or from about 16 mm to about 20 mm. In some embodiments,antenna coil 106 may have a diameter of approximately 6 mm, 7 mm, 8 mm,10 mm, 11 mm, 12 mm, or 13 mm.

In some embodiments, antenna coil 106 may have a height or thickness h,which may be less than the turn diameter t of antenna coil 106. Theheight (or thickness) h may generally be commensurate with the totalthickness of the number of individual wire turns forming antenna coil106. Height h may range, e.g., from about 0.2 mm to about 5 mm, such as,for example, from about 0.2 mm to about 0.5 mm, from about 0.2 mm toabout 1 mm, from about 0.5 mm to about 1 mm, from about 0.5 mm to about1.5 mm, from about 0.7 mm to about 1.2 mm, from about 0.7 mm to about1.8 mm, from about 0.9 mm to about 1.4 mm, from about 0.9 mm to about 2mm, from about 1 mm to about 1.5 mm, from about 1 mm to about 2.4 mm,from about 1.2 mm to about 1.8 mm, from about 1.4 mm to about 1.9 mm,from about 1.5 mm to about 2.0 mm, from about 1.8 mm to about 2.2 mm,from about 2 mm to about 2.4 mm, from about 2.2 mm to about 2.5 mm, fromabout 2.4 mm to about 2.8 mm, from about 2.5 mm to about 3 mm, fromabout 2.6 mm to about 3.5 mm, from about 2.8 mm to about 3.6 mm, fromabout 3 mm to about 4 mm, from about 3.5 mm to about 4.2 mm, or fromabout 3.8 mm to about 4.5 mm. In some embodiments, antenna coil 106 mayhave a height h of approximately, e.g., 1.5 mm, 1.7 mm, 1.9 mm, 2 mm,2.1 mm, 2.2 mm, or 2.3 mm.

In some embodiments, antenna coil 106 may have an elongated shape, e.g.such that a turn diameter t of antenna coil 106 may be longer than,e.g., height h of antenna coil 106. In other embodiments, however,antenna coil 106 may have other shapes, such as, e.g., circular shapes,square shapes, etc.

Antenna core 104, around which antenna coil 106 may be wound, may bemade of a biocompatible, non-conductive, non-ferromagnetic material. Inother words, the material of antenna core 104 is neither attracted norrepelled by an externally-applied magnetic field. For example, antennacore 104 may be made of PEEK, ceramic, silica (glass), and/or anothertype of biocompatible plastic. In some embodiments, antenna coil 104 maybe made of a material that may be able to withstand high temperatures(e.g., temperatures ranging up to about 250 degrees centigrade). Antennacore 104 may also be shaped in such a way that facilitates the shapingof antenna coil 106 around it. For example, as depicted in FIGS. 1A-2B,antenna core 104 may have notched ends 104 e in which turns of woundantenna coil 106 may sit. In alternate embodiments, antenna core 104 maynot have notched ends. Antenna core 104 may have dimensions configuredto support a coil of a desired size and shape. For example, antenna core104 may have a length around which antenna coil 106 may be wound, thelength ranging from about 4 mm to about 20 mm, such as, for example,from about 4 mm to about 15 mm, from about 4 mm to about 10 mm, fromabout 5 mm to about 7 mm, from about 6 mm to about 8 mm, from about 7 mmto about 10 mm, from about 9 mm to about 13 mm, from about 10 mm toabout 15 mm, from about 12 mm to about 17 mm, from about 15 mm to about19 mm, or from about 16 mm to about 20 mm. In some embodiments, antennacore 104 may have a length of approximately 4 mm, 5 mm, 6 mm, 7 mm, 8mm, 10 mm, 11 mm, 12 mm, 13 mm, or 14 mm.

In some embodiments, antenna core 104 may have a width perpendicular tothe length of antenna core 104 (parallel to width x of antenna coil106), and a thickness perpendicular to both the length and the width ofantenna core 104 (parallel to height h of antenna coil 106). The widthand the thickness of antenna core 104 may each range from about 0.5 mmto about 20 mm, such as, for example, from about 0.5 mm to about 15 mm,from about 0.5 mm to about 10 mm, from about 0.5 mm to about 5 mm, orfrom about 0.5 mm to about 3 mm. In some embodiments, each of the widthand the thickness of antenna core 104 may be approximately 0.5 mm, 1 mm,2 mm, or 3 mm.

In alternative embodiments, antenna 102 may simply include antenna coil106 and no antenna core 104, such that antenna coil 106 is not woundaround a solid object (e.g., it is an air coil surrounding air).

Chip 110 may be, for example, an integrated circuit (IC) chip. Forexample, in some embodiments of the present disclosure, chip 110 may bean application-specific integrated circuit (ASIC) chip, either with orwithout a built-in capacitor. In some embodiments, chip 110 may have,for example, printed circuit board (PCB) integration. In someembodiments, chip 110 may be an RFID chip. Chip 110 may be configured tosense, receive, and send a wide variety of data. In some embodiments,for example, chip 110 may be an ASIC designed to sense environmentalconditions. For example, chip 110 may be a pressure ASIC. In furtherembodiments, chip 110 may be combined with one or more gauges configuredto sense environmental conditions, such as a physical strain gauge, apressure gauge, or a temperature gauge. In some embodiments, chip 110may be an ASIC or other type of chip programmed with identifying data,such as a serial number, such that when provided with power, chip 110will return such identifying data. Additional examples of sensors andinformation which may be paired or associated with chip 110 aredescribed further herein.

Although one chip 110 is depicted, in some embodiments, two or morechips may also be used in assembly 101. In such cases, the two or morechips may each share a single functionality, or may each carry adistinct functionality, e.g., each may carry different identifyinginformation or may be paired with different sensors.

Chip 110 may include bond pads 112, which may be used to connect chip110 with antenna coil ends 108. Bond pads 112 may, for example, beembedded into an etched surface of chip 110 such that they do notprotrude from the surface of chip 110. Bond pads 112 may be, forexample, made out of a nonmagnetic metal, such as, for example, gold.

Antenna coil ends 108 may be connected to bond pads 112 via, forexample, thermal compression, laser welding, soldering, or a crimpconnection. Alternately, antenna coil ends 108 may be connected to bondpads 112 by other methods known in the art, such as using a conductiveadhesive.

Capsule 114 may enclose assembly 101, as well as an inner space 116surrounding assembly 101. Capsule 114 may be made from, for example, abiocompatible material, such as glass (e.g., silicate glass, such as asoda-lime silicate glass), or a biocompatible plastic. Capsule 114 maybe the outermost portion of transponder 100, and may therefore have asize and shape corresponding to a desired size and shape of transponder100. Exemplary sizes and shapes of transponder 100 have been previouslydisclosed herein. Capsule 114 may, for example, include two pieces,which may be assembled around assembly 101.

Inner space 116 may be a vacuum, or may contain air, a liquid, solid, orgel material. In some embodiments, inner space 116 may be fully orpartially filled with a liquid, solid, or gel material. For example, insome embodiments, inner space 116 may be filled with a liquid, solid, orgel material configured to provide transponder 100 with shockresistance. In some embodiments, inner space 116 may be fully orpartially filled with an adhesive, such as, e.g., a glue. In suchembodiments, the glue may be a biocompatible adhesive, such as an epoxyor an acrylate adhesive. In some embodiments, the glue may be aphotoinitated-curing acrylate adhesive. In some embodiments, the gluemay be a shock-resistant glue. In some embodiments, the glue may be aglue that may be exposed to temperatures of up to about 250 degreescentigrade, and after cooling to room temperature may have a similar orthe same temperature, viscosity, and other characteristics as it hadbefore being exposed to the temperatures of up to about 250 degreescentigrade.

In some embodiments, half of inner space 116 may be filled with aliquid, solid, or gel material, such as an adhesive as described above.In other embodiments, at least 30% of inner space 116 may be filled. Inother embodiments, between about 30% and about 50% of inner space 116may be filled. In further embodiments, over 60% of inner space 116 maybe filled. In further embodiments, between about 50% and about 100% ofinner space 116 may be filled, such as about 55%, about 65%, about 75%,about 85%, about 90%, about 95%, or about 100% of inner space 116. Inyet further embodiments, between about 80% and about 100% of inner space116 may be filled. In some embodiments, about 90% or more of inner space116 may be filled. In yet further embodiments, about 95% or more ofinner space 116 may be filled.

Multiple configurations of transponders according to the presentdisclosure may be based on exemplary transponder 100. For example, chip110 may have a variety of configurations and specifications, dependingon the availability of chips in the art. Based on, e.g., the type ofchip used, the configuration of a transponder according to the presentdisclosure may change.

One example of an alternative embodiment of transponder 100 is depictedin FIGS. 2A and 2B.

FIGS. 2A and 2B depict, in schematic form, a top-down view (FIG. 2A) anda side view (FIG. 2B) of transponder 200, which may be anotherconfiguration of a transponder according to the present disclosure. Intransponder 200, an assembly 118 may include antenna 102, chip 110, acapacitor 120 external to chip 110, and a base 122 to which the chip 112and the capacitor 120 may be attached. Antenna coil ends 108 of antennacoil 106 may extend through base 122, or may attach to an electricalconductor extending through base 122, to positive and negative leads ofcapacitor 120 so as to create a circuit with capacitor 120. Wires 123may connect capacitor 120 to bond pads 112 of chip 110. A capsule 124may enclose assembly 118 and inner space 116 surrounding assembly 118.

Capacitor 120 may be included in transponder 200, separate from chip110. In transponder 200, chip 110 may or may not include a built-incapacitor. As depicted in FIGS. 2A and 2B, assembly 118 of transponder200 may include base 122, to which capacitor 120 and chip 110 may beinstalled, and to which antenna coil ends 108 of antenna 102 may beattached. Base 122 may provide, for example, stability and structure toassembly 118, and may also, as depicted, serve as a medium through whichthe capacitor 120 may be connected to antenna coil ends 108 of antenna102, as well as chip 110.

Base 122 may be made of any non-ferromagnetic, biocompatible material,such as, e.g., any material suitable for use in forming antenna core 104(e.g., PEEK or other biocompatible plastic). Additionally, base 122 may,in some embodiments, include conductive elements through which antenna102, capacitor 120, and/or chip 110 may be connected. For example, insome embodiments, base 122 may include conductive tracks or padsconfigured to support connections between antenna coil ends 108,capacitor 120, and chip 110. In some embodiments, a portion or all ofbase 122 may be a circuit board, such as, e.g., a printed circuit board.

As depicted schematically in FIGS. 2A and 2B, antenna coil ends 108 maybe attached to base 122 by, for example, thermal compression, welding,soldering, a crimp connection, or other known attachment types.Similarly, capacitor 120 may be connected to base 122 by, e.g., thermalcompression, welding, soldering, etc. A connection may extend throughbase 122 from one attached antenna coil end 108 to a positive lead ofcapacitor 120, and from the other attached antenna coil end 108 to anegative lead of capacitor 120. Capacitor 120 may further be connectedto chip 110, which may also be attached to base 122 by, for example,wires 123 attached to bond pads 112 via thermal compression, welding,soldering, a crimp connection, or other attachment types known in theart.

In yet further embodiments, assembly 118 of transponder 200 may notinclude base 122. In such embodiments, antenna coil ends 108 may bedirectly connected to capacitor 120 by, for example, thermalcompression, welding, soldering, a crimp connection, or the like, andcapacitor 120 may likewise be connected to chip 110. As with transponder100, antenna 102 in transponder 200 may or may not include antenna core104.

In the embodiments depicted in FIGS. 2A and 2B, capsule 124 may besimilar in construction to capsule 114. In some embodiments, dependingon the size and shape of capacitor 120, capsule 124 may need to belarger than capsule 114, in order to accommodate capacitor 120.Similarly, inner space 124 of transponder 200 may be larger than innerspace 116 of transponder 100. Inner space 124 may be a vacuum, or may befilled with a variety of substances, as has been disclosed with respectto inner space 116.

In some embodiments of transponders according to the present disclosure(e.g., transponders 100, 200), the transponders may not be enclosed in acapsule, e.g., having an inner space. Instead, in some embodiments,transponders (e.g., transponders 100, 200) may just include componentsof, e.g., assemblies 101, 118.

In some embodiments of transponders according to the present disclosure,a chip of the transponder (e.g. chip 110) may not have a built-incapacitor. In such embodiments, a capacitor external to chip 110 (e.g.capacitor 120) may serve as primary electrical energy storage for 120to, for example, power a chip, such as chip 110. In further embodiments,such as embodiments in which a chip (e.g., chip 110) does have abuilt-in capacitor, the added capacitor (e.g., capacitor 120) mayprovide additional power to the chip, so that the chip may be poweredfor a longer period of time or may be supplied a greater amount of powerthan with simply a built-in capacitor internal to, e.g., chip 110. Addedcapacitor 120 in transponder 200 may, for example, allow transponder 200to store a greater amount of electrical energy than a transponderwithout capacitor 120.

Transponders according to the present disclosure (such as, e.g.,transponders 100, 200 depicted in FIGS. 1A-2B) may be, for example,configured to transmit data via low wavelength RF couplingcommunication. For example, data may be communicated via RF low wavetransmissions having a frequency ranging from about 100 kHz to about 400kHz, such as, e.g., from about 200 kHz to about 300 kHz, from about 100kHz to about 200 kHz, from about 120 kHz to about 150 kHz, from about125 kHz to about 145 kHz, or from about 130 kHz to about 135 kHz. Insome aspects, the communication frequency of assembly 101 may be about134.2 kHz.

Transponders according to the present disclosure, such as transponders100, 200, may be adapted for temporary or permanent implantation with animplantable medical device. For example, one or more transpondersaccording to the present disclosure may be partially or fully enclosedin a biocompatible material, and integrated into the medical device.Exemplary biocompatible materials include silicone and other polymersand polymer coatings suitable for temporary or permanent medicalimplantation. In some aspects of the present disclosure, a transpondermay be placed between two portions of silicone that form a biocompatibleenvelope around the transponder.

Transponders according to the present disclosure (e.g., transponders100, 200) may be incorporated into an interior space of a medicaldevice, or attached to an inner or outer surface of the medical device.In some aspects, the medical device may be a breast implant or tissueexpander, and the transponder(s) may be suspended inside the breastimplant or tissue expander. In other aspects, the transponder(s) may beattached to an inner or outer surface of a shell or outer wall of thebreast implant or tissue expander, or may be incorporated into a shellor wall of the breast implant or tissue expander, for example betweenlayers comprising the shell or wall of the breast implant or tissueexpander. In at least one example, the transponder(s) may be permanentlyattached or encased in a silicone plastic case and integrated into atissue expander or medical implant by dielectrically sealing or bondingthe encased transponder(s) to the shell of the tissue expander ormedical implant. In some examples, the transponder(s) encased insilicone may be placed into an inner volume of the tissue expander ormedical implant, e.g., such that the transponder(s) is/are free floatingin the inner volume or suspended in a material filling the inner volumeof the tissue expander or medical implant.

According to some aspects of the present disclosure, a medical devicemay include a plurality of transponders (e.g., transponders 100, 200),e.g., 2, 3, 4, 5, or 6 or more transponders. Each transponder may bespaced apart from the other sensor(s) in a predetermined spacinginterval. Such combinations of transponders in a medical device may beuseful for determining orientation information, such as changes inorientation of the medical device, displacement of the medical device,changes in an amount of material between the transponders, and/orchanges in a physical or chemical property of the material between thetransponders. Such changes may be determined, for example, by measuringimpedance between two or more transponders.

Further, for example, two or more medical devices implanted in a patientmay include transponders with the ability to communicate and/or provideinformation relevant to each other. For example, for a patient with twobreast implants, each implant may include one or more transponders incommunication with the transponder(s) in the other implant.Additionally, or alternatively, the transponder(s) of each implant maybe configured to provide data in reference to a common anatomicalfeature of the patient and/or a common reference point of one of theimplants.

Transponders 100, 200 may, for example, be active, passive, or bothactive and passive. In cases of permanent implants or medical devicesintended for a relatively long-term implantation, passive transpondersmay avoid concerns of recharging power cells, cycle life, and/orpossible corrosive properties of certain materials (e.g., dissimilarmaterials) that may be used in the design of batteries for activesensors. Data may be transmitted, received, stored and/or analyzed bythe transponders either actively and/or passively. For example, data maybe transmitted via radiofrequency from a transponder to an externalreader (external to the implant) configured to receive and/or analyze orotherwise process the data. Exemplary embodiments of such readers aredisclosed further herein. Such a reader may be implanted within thepatient, or may be external to the patient and attached or not attachedto the patient. According to some aspects of the present disclosure,data may be transferred between a transponder (e.g., transponder 100,200) and a reader within a distance of about 10 feet separating thetransponder from the reader, e.g., a distance of about 7 feet, about 5feet, about 3 feet, or about 1 foot. For example, in some aspects of thepresent disclosure, the transponder (e.g., transponder 100, 200) may beconfigured to send and/or receive information within a range of fromabout 1 inch to about 5 feet, from about 2 inches to about 3 feet, fromabout 3 inches to about 1 foot, from about 2 inches to about 9 inches,from about 4 inches to about 8 inches, or from about 4 inches to about 6inches.

Transponders (e.g., transponders 100, 200) may be configured to detectand/or measure various stimuli or parameters. For example, transpondersaccording to the present disclosure may be configured to detect and/ormeasure one or more of acoustic data, temperature, pressure, light,oxygen, pH, motion (e.g., accelerometers), cyclo-rotation (e.g., gyrosensors), or any other physiological parameter, using sensors known inthe art coupled to a chip of a transponder, e.g., chip 110 oftransponders 100, 200. For example, an exemplary pH sensor may include ameasuring electrode, a reference electrode, and a temperature sensor.The sensors may include a preamplifier and/or an analyzer or transmitterto assist in displaying the data. In some aspects, the sensors may beconfigured to determine the location and orientation of an implantedmedical device, e.g., to assess any improper changes in location ororientation after initial implantation.

The sensors may be calibrated with an appropriate reference or standardin order to provide an accurate measurement value, or absolute orrelative change in values. For example, temperature sensors may becalibrated according to one or more reference temperatures, and pressuresensors may be calibrated to indicate a change in pressure.

In some examples, the implantable medical device may include atransponder and/or sensor package comprising a transponder incombination with one or more other transponders, sensors, and/oradditional electronic components. The transponder(s), sensor(s), andelectronic components may be coupled together or otherwise incommunication with each other. For example, an exemplary transponderand/or sensor package may include one or more transponders coupled toone or more sensors for measuring pressure, temperature, acoustic data,pH, oxygen, light, rotational movement or cycles, or a combinationthereof. A transponder and/or sensor package may comprise individualintegrated circuits coupled together via a PCB or fully integrated intoan ASIC.

The transponders (e.g., transponders 100, 200) of the present disclosuremay be read/write, e.g., where data may be written into or otherwiseassociated with each transponder by a user in order to be read by asuitable device, such as an external reader. Such data may include aunique device identifier for the transponder, the transponder and/orsensor package, and/or the medical device. Information provided by theunique device identifier may include, e.g., serial number(s),manufacturer name(s), date(s) of manufacture, lot number(s), and/ordimensions of the medical device and/or sensor(s). For example, one ormore transponders (e.g., transponders 100, 200) associated with a breastimplant may include information on the implant's dimensions (e.g., sizeand/or volume), manufacturer, date of manufacture, and/or lot number.Additionally, or alternatively, the one or more transponders (e.g.,transponders 100, 200) associated with the breast implant may includeinformation on the transponder(s) and/or sensor(s) paired with the oneor more transponder(s), such as the type of data collected/measured,manufacturer, date of manufacture of the implant, and/or serialnumber(s) of the implant and/or implant package, the type, dosage,and/or composition of ancillary coatings or materials used inassociation with the implant, etc.

Integration of acoustic sensors with transponders (e.g., transponders100, 200) into implantable medical devices may enhance auscultation,e.g., allowing for monitoring and/or examining the circulatory system(e.g., via heart sounds relating to cardiac output or structuraldefects/disorders), respiratory system relating to pulmonary function(e.g., via breathing sounds), and/or the gastrointestinal systemrelating to obstructions and ulcerations (e.g., via bowel sounds). Theacoustic sensors may include lever and MEMS (microelectromechanicalsystem) devices. Examples of acoustic sensors that may be used hereininclude, but are not limited to, accelerometers (e.g., measuringvibrational noise), thermal sensors (e.g., measuring thermomechanicalnoise), and piezocapactive sensors, among other types of acousticsensors. The acoustic sensors may operate manually when provided power(e.g., when a transponder paired with the sensors is coupled with areader). Capacitors (e.g., capacitor 120 in transponder 200, or abuilt-in capacitor in chip 110) and/or batteries may allow a transponder(e.g., transponder 100, 200) to gain information and store theinformation and transfer data when asked or coupled to anotherelectronic device.

Further, transponders according to the present disclosure may beconfigured to enhance acoustic data. Enhancing acoustic sounds mayinclude algorithms that are trained with known sounds to give referenceas to an amount or degree of change, and/or for elimination ofnon-significant noise (e.g., signals that may be an artifact ofmeasurement technique) that may interfere with the generation of “clean”signals providing meaningful information about the patient. Suchalgorithms may be loaded onto a chip (e.g., chip 110) of a transponder(e.g., transponders 100, 200).

As mentioned above, transponders such as transponders 100, 200 may beconfigured to communicate with an external reader for processing thedata, e.g., by filtering noise from raw data. For example, thetransponders may be used in combination with algorithms that collate andanalyze filtered data, e.g., taking in raw data from the sensors at aminimal transmission (threshold) format based on pre-programmedparameters (e.g., data obtained from reference tables). Such algorithmsmay be designed to combine relevant integrated data specific to providea proper signal indicative of a mechanical or clinical problem, whichthen may be processed by a reader. Readers are described in furtherdetail elsewhere in this disclosure. The reader may include a graphicdisplay such as an LED display, and may have parameters established inthe firmware of the reader to present the data output on the displayand/or provide a notification signal. For example, the notificationsignal may be a recommendation displayed on the reader that the patientcontact his/her caregiver or clinician to follow up on a particularaction item. For example, the reader may suggest examination ormodification of a particular aspect of the implanted medical device(e.g., add more saline solution to a tissue expander via a syringe,etc.).

Further uses, systems, and combinations of transponders, sensors, andreaders, are also disclosed elsewhere herein.

Integrated Port Assemblies and Locator Coils

The present disclosure also includes low artifact transponders that maybe used in order to locate particular parts or characteristics ofimplanted medical devices. For example, some implanted medical devicesmay require alteration or adjustment after implantation. As an example,tissue expanders may be used during breast reconstruction oraugmentation surgery in order to incrementally expand chest tissue overtime, so that the tissue is able to accommodate a more permanentimplant. Tissue expanders according to the present disclosure may alsobe used for procedures other than breast augmentation andreconstruction.

Tissue expanders may be inflated manually and/or electronically, e.g.,with a syringe or other suitable device for introducing and withdrawinga fluid (e.g., a liquid or gaseous fluid) or gel into the tissueexpanders. The tissue expanders may be inflated with saline solution,which may be supplied in a sterile pouch, such as the Hydropac® productsby Lab Products, Inc. In some aspects, inflation may be performedwirelessly, e.g., by communicating with an internal chamber or cylinderof compressed air.

According to some aspects of the present disclosure, the tissue expandermay include one or more pressure sensors and/or one or more straingauges, which may be coupled with, e.g., transponders (e.g.,transponders 100, 200). Such sensors may allow for the continuous and/orintermittent measuring of pressure to optimize, regulate, and/orwirelessly control the expansion and deflation of such tissue expanders.A transponder/sensor package for a tissue expander (including, e.g.,sensors for measuring pressure, temperature, acoustic data, pH, oxygen,light, or a combination thereof) may be contained in a silicone moldedenclosure. In at least one example, the tissue expander may include atleast one of a pressure sensor or a strain gauge coupled to, or embeddedin, the outer wall (shell) of the tissue expander. In some aspects, thetissue expander may include a sensor/transponder package (including,e.g., sensors for measuring pressure, temperature, acoustic data, pH,oxygen, light, or a combination thereof), which may have a fixedlocation relative to the tissue expander. Such sensor/transponderpackages may be paired with readers, which are described in furtherdetail elsewhere in this disclosure.

A tissue expander may include a port, through which fluids may beinjected into the tissue expander after the tissue expander has beenimplanted into a patient. A port may be located within an aperture in ashell of a tissue expander, the aperture being sized specifically to fitthe port. Thus, the port may be implanted along with a tissue expanderand may not be immediately detectable from the exterior of the patient.Advantageously, transponders and/or coils according to the presentdisclosure may be combined with, for example, tissue expander ports andvalve assemblies, in order to assist in detection of the ports and valveassemblies. By having a transponder and/or antenna coil installed withina tissue expander port or valve assembly, a physician may be able tononinvasively identify the appropriate location of a port in order toinject saline solution into a patient in whom the tissue expander isimplanted. As with transponders 100, 200, such transponders, antennacoils, and/or valve assemblies may be made of materials that arealternatives to ferromagnetic materials, which can cause an imagingartifact under magnetic resonance imaging. For example, thetransponders, coils, and/or and associated valve assemblies disclosedherein may comprise non-ferromagnetic materials, such aspoly-ether-ether-ketone (PEEK) or other plastics.

FIGS. 3A-3C show an exemplary valve assembly 300 according to thepresent disclosure, including a casing 302, a coil 304, and a chip 306connected to coil 304. FIG. 3A depicts a three-dimensional view of valveassembly 300, FIG. 3B depicts a side view of valve assembly 300, andFIG. 3C depicts a top-down view of valve assembly 300. Casing 302 mayhave a circular well portion 308 in which coil 304 and chip 306 arehoused. Well portion 308 may have a lip 309 of a wall 309A whichprotrudes inward over well portion 308. Casing 302 may also include aninner chamber 307 centered within well portion 308 and surrounded by awall 311. A circumferential inner ledge 323 may protrude into innerchamber 307. As depicted in FIG. 3B, a portion of inner chamber 307 mayextend to a deeper depth than well portion 308, such that casing 302 hasa center portion 312 that protrudes into a medical implant (e.g., atissue expander) from the rest of casing 302. Center portion 312 mayhave a reinforced tip 315 at the furthest end of its protrusion. One ormore fluid holes 314 may pass from inner chamber 310 through centerportion 312. Casing 302 may also have a circumferential outer ledge 317around wall 311. Outer ledge 317 may include one or more notches 319.

Valve assembly 300 may be configured for installation in a shell of atissue expander. Valve assembly 300 may be made of a biocompatible,non-magnetic, non-ferromagnetic material, such as, for example, moldedPEEK. Valve assembly 300 may be of a hardness sufficient to preventbeing pierced by a cannula, such as the cannula of a syringe used toinject fluid into a tissue expander in which valve assembly 300 isinstalled. Valve assembly 300 may be sized and shaped to allow for acoil 304 to fit within a circumference of valve assembly 300.

Coil 304 may be a wound radiofrequency (RF) antenna coil made of, e.g.,a metal wire, such as, e.g., copper wire or aluminum wire. In someembodiments, coil 304 may be made of enameled wire, e.g., wire coated ina polymer. Suitable polymers may include, e.g., polyvinyl formal(Formvar), polyurethane, polyamide, polyester, polyester-polyimide,polyamide-polyimide (or amide-imide), and polyimide. In someembodiments, coil 304 may be made of enameled copper wire, such as,e.g., Elektrisola enameled copper wire.

Coil 304 may be sized and shaped so as to frame a core, or centerportion, through which a cannula may pass into a central chamber 307 ofvalve assembly 300. Coil 304 may also be sized and shaped so as to bedetected by, e.g., a reader configured to detect the center of the woundcoil. In this manner, coil 304 may serve as, e.g., a “targeting element”for a reader being used to search for a valve assembly, e.g., valveassembly 300. In some embodiments, coil 304 may have a regular hollowcylindrical shape, and may have an outer diameter, e.g., ranging fromabout 10 mm to about 50 mm, such as, for example, from about 10 to about40 mm, from about 15 mm to about 35 mm, from about 15 mm to about 25 mm,from about 20 mm to about 35 mm, or from about 22 to about 27 mm. Insome embodiments, for example, coil 304 may have an outer diameter ofabout 24 mm, about 24. 6 mm, about 25 mm, about 25.3 mm, about 26 mm, orabout 26.2 mm.

In some embodiments, coil 304 may have an inner diameter, e.g., rangingfrom about 10 mm to about 50 mm, such as, for example, from about 10 mmto about 40 mm, from about 10 mm to about 35 mm, from about 15 mm toabout 35 mm, from about 15 mm to about 30 mm, from about 15 mm to about25 mm, or from about 18 mm to about 22 mm. In some embodiments, forexample, coil 304 may have an inner diameter of about 18 mm, about 19mm, about 19.5 mm, about 20 mm, about 20.1 mm, about 20.3 mm, about 20.4mm, about 20.5 mm, about 20.6 mm, about 20.7 mm, about 21 mm, or about22 mm.

In some embodiments, coil 304 may have a height ranging from about 1 mmto about 20 mm, such as from about 1 mm to about 15 mm, from about 1 mmto about 13 mm, from about 1 mm to about 10 mm, from about 1 mm to about8 mm, from about 1 mm to about 5 mm, or from about 1 mm to about 4 mm.For example, in some embodiments, coil 304 may have a height of about 1mm, about 2 mm, about 2.1 mm, about 2.2. mm, about 2.5 mm, about 2.7 mm,about 2.8 mm, about 2.9 mm, about 3 mm, about 3.2 mm, about 3.4 mm,about 3.6 mm, about 3.8 mm, about 3.9 mm, or about 4.0 mm.

Coil 304 may be formed of any number of turns sufficient to be inducedby an external reader (e.g., reader 800, which is described furtherherein). For example, in some embodiments, coil 304 may be formed ofbetween about 10 and about 2000 turns. In some embodiments, for example,coil 304 may be formed of between, e.g., about 100 and about 1500 turns,about 500 and about 1100 turns, or about 800 and about 1000 turns. Insome embodiments, for example, coil 304 may be formed of, e.g., about500, about 700, about 800, about 1000, about 1100, or about 1200 turns.

Chip 306 may be an RF chip known in the art, such as, e.g., chips thathave been described elsewhere herein (e.g., chip 110). Generally,disclosures herein with respect to chip 110 may apply with respect tochip 306 as well. In some embodiments, for example, chip 306 may be anASIC. Chip 306 may or may not include a capacitor. In some embodiments,chip 306 may be an ASIC programmed with identifying data, such as aserial number, such that when provided with power, chip 110 will returnsuch identifying data. In some embodiments, chip 306 may be a sensor, ormay be paired with sensors, as has been described elsewhere herein withrespect to chip 110. In alternate embodiments of valve assembly 300,there may be no chip 306. In such cases, coil 304 may be used primarilyas a targeting element for assisting in locating valve assembly 300.

Casing 302 of valve assembly 300 may be sized and shaped to accommodatecoil 304 and chip 306 in well portion 308, as well as inner chamber 307.Well portion 308 of valve assembly 300 may have a generally circularshape, in order to accommodate coil 304 and, e.g., chip 306 connected tocoil 304. Well portion 308 of valve assembly 300 is depicted as beingopen in FIGS. 3A-3C; however, in some embodiments, circular well portion308, containing coil 304 and chip 306, may be closed and sealed off fromthe rest of valve assembly 300 by, e.g., a biocompatible material, suchas a biocompatible material from which the body of casing 302 is made(e.g., PEEK), or another biocompatible material (e.g., silicone).

Lip 309, which may protrude over well portion 308, may be configured tointerlock with, e.g., a dome that may cover valve assembly 300. Such adome may be, for example, integrated port dome 310, which is shown in,e.g., FIG. 4, and is described further herein. In alternate embodiments,lip 309 may protrude in a different direction (e.g., outward and awayfrom well portion 308), or may include intermittent protrusions forattachment to, e.g., a dome that may cover valve assembly 300 in adifferent manner.

Inner chamber 307 is radially inward of coil 304 and well 308. Innerchamber 307 may, in some embodiments, be cylindrical-shaped,bowl-shaped, or both. In some embodiments, inner chamber 307 may have adepth that is deeper than, e.g., well portion 308, such that some or allof inner chamber may extend into center portion 312, which may protrudebelow the rest of casing 312 (e.g, well portion 308), as depicted in,e.g., FIGS. 3B and 4. Inner chamber 307 may be configured to receive,e.g., fluid from, e.g., a cannula, syringe, or other fluid injectiondevice. Fluid holes 314 may extend from inner chamber 307 through casing302 and out center portion 312, such that fluid may pass from innerchamber 307 through fluid holes 314 and into, for example, a medicalimplant into which valve assembly 300 is installed. In some embodiments,fluid holes 314 may include valves, e.g., one way valves (e.g., duckbill valves), configured to allow fluid to pass from inner chamber 307outward into, e.g., a medical implant, and not back into inner chamber307. A bottom surface of inner chamber 307 may be reinforced by innertip 315, so as to prevent penetration by, e.g., a cannula, syringe, orother injection means.

FIG. 4 depicts a side view of an integrated port assembly 400, which mayinclude valve assembly 300 (of which a cross-sectional view ispresented), and an integrated port dome 310. Integrated port dome 310may include a step 316, which may be configured to fit against the edgesof an aperture in a wall of an implant into which integrated portassembly 400 may be installed, so that patch portion 314 sits over theimplant wall. Integrated port dome 310 may also have a flange 312, whichmay be configured to interlock with lip 309 of valve assembly 300, thusconnecting valve assembly 300 to integrated port dome 310. Patch portion314 is wider than flange 312 and valve assembly 300.

Integrated port dome 310 may be made of a biocompatible materialsuitable for interfacing with patient tissue, as well as with a surfaceof an implant into which integrated port assembly 400 may be installed.Some or all of integrated port dome 310 may be made of a material thatis penetrable by, e.g., a cannula, syringe, or other injection device,such that an injection device may penetrate integrated port dome 310 andinject fluid within inner chamber 307 of valve assembly 300. In someembodiments, integrated port dome may be made of a self-sealingmaterial, such that when integrated port dome 310 is penetrated by aninjection device and the injection device is subsequently removed,integrated port dome will seal the penetration site and prevent fluidsfrom escaping valve assembly 300. In some embodiments, integrated portdome 310 may be made of a silicone material. In some embodiments, forexample, integrated port dome 310 may be made of a silicone materialwhich may be vulcanized.

Integrated port dome 310 may be sized and shaped to, e.g., interlocksecurely with valve assembly 300. As depicted in, e.g., FIGS. 5B and 5C,described further below, flange 312 of integrated port dome 310 may befurther sized and configured to cover any opening in well portion 308 ofvalve assembly 300, when interlocked with lip 309 of valve assembly 300,thus sealing coil 304 (and chip 306) within well 308 and preventing theexposure of coil 304 and chip 306 to fluids.

FIGS. 5A, 5B, and 5C depict integrated port assembly 400 installed in anexemplary implant shell 500. Implant shell 500 may be, for example, ashell of a tissue expander, as depicted in FIG. 5A. In some embodiments,implant shell may be made of silicone; however, implant shells of anybiocompatible material may be used in conjunction with integrated portassembly 400. Integrated port assembly 400 may be installed in anaperture 502 of implant shell 500. Valve assembly 300 of integrated portassembly may be located inside implant shell 500. Integrated port dome310 may be attached to valve assembly 300, and patch portion 314 may belocated outside implant shell 500. In FIG. 5A, patch portion 314 ofintegrated port dome 310 is depicted by a dotted line, showing howintegrated patch portion 314 may overlap with some surface area ofimplant shell 500. Other portions of integrated port dome 310 are notdepicted, so as to depict valve assembly 300. In some embodiments, patchportion 314 and implant shell 500 may be attached to one another, e.g.,by vulcanization, adhesion, or other method.

FIG. 5B depicts a cross-sectional view of integrated port assembly 400installed in implant shell 500. As depicted in FIG. 5B, an edge ofaperture 502 of implant shell 500 may be angled in a mannercomplementary to an angle of step 316 of integrated port dome 310, so asto fit snugly against step 316. In such a manner, and in combinationwith the overlap and attachment of patch portion 314 with implant shell500, integrated port assembly 400 may be sealed and secured withinaperture 502 of implant shell 500.

FIG. 5C depicts the same cross-sectional view of integrated portassembly 400 installed in implant shell 500 as FIG. 5B. FIG. 5C alsodepicts how an exemplary cannula 504 may penetrate integrated port dome310 to reach inner chamber 307. Cannula 504 may be configured to deliverfluid into inner chamber 307, and subsequently to the inside of implantshell 500. As has been previously described, integrated port dome 310may be made of a self-sealing material, such as a silicone material,such that when cannula 504 is withdrawn, integrated port dome 310 sealsfluid within inner chamber 307 and implant shell 500.

FIG. 6 depicts another exemplary integrated port assembly 600, which mayinclude a valve assembly 610 and an integrated port dome 620. Valveassembly 610 may include a main chamber 612 surrounded by a wall 615having a lip 619. Lip 619 has an inner edge 619 E. Main chamber 612 mayhave a top opening defined by edge 619E configured to face integratedport dome 620, and may accommodate a plug 621 of integrated port dome620. Wall 615 of main chamber 612 may have one or more fluid holes 618that may pass from main chamber 612 out of the valve assembly 610. Acoil 616 may be located in a coil housing 614 which is separated frommain chamber 612 by a needle stopping surface 617, such that coil 616 iscentered beneath main chamber 612. Integrated port dome 620 may have apatch 622, which may have a wider width than plug 621 and valve assembly610, and may be integral with plug 621. A flange 626 between patch 622and plug 621 may be configured to accommodate and interlock with lip 619of valve assembly 610. Integrated port dome 620 may also have a step 624configured to interface with a wall of an implant into which theintegrated port assembly 600 may be installed.

Aspects of integrated port assembly 600 may, in general, be similar toaspects of integrated port assembly 400. For example, in someembodiments, valve assembly 610 may be made of any of the materials outof which valve assembly 300 may be made, such as biocompatible,non-ferromagnetic materials, such as PEEK. Further, main chamber 612 ofvalve assembly 610 may have a function similar to inner chamber 307 ofvalve assembly 300, in that main chamber 612 may be sized, shaped, andconfigured to receive fluids from, e.g., a cannula, syringe, or otherfluid deposition device. An inner surface 617 of main chamber 612 may beconfigured to prevent or resist puncturing by, e.g., a cannuladepositing fluid within main chamber 612. For example, inner surface 617may be made of a material having a density, hardness, or thicknessconfigured to prevent or resist puncturing by a fluid deposition device.In some embodiments, main chamber 612, including inner surface 617, maybe made of biocompatible PEEK.

Coil 616 may be similar, in terms of size, shape, configuration,materials, and construction, to coil 304, which has previously beendisclosed above with respect to FIGS. 3A-5C. Coil 616 may be housed in acoil housing 614. In some embodiments, coil housing 614 may be sealedshut, such that no fluids may enter or exit coil housing 614. In someembodiments, coil housing may be cylindrical, as shown, and may becoaxial with main chamber 612, such that coil 616 is also coaxial withmain chamber 612. In this manner, the location of coil 616 may be usedto locate the center, or the approximate center, of main chamber 612.Coil housing 614 is depicted as having a smaller circumference than,e.g. main chamber 612. However, in some embodiments, coil housing 614may have a circumference that is as large as, or nearly as large as,main chamber 612.

Though not pictured, coil 616 may be coupled to a chip, similar to chip306 connected to coil 304. Such a chip may have any of thecharacteristics and capabilities of chips that are otherwise disclosedherein.

Integrated port dome 620 may be similar in shape, structure, andconstruction materials to integrated port dome 310 of integrated portassembly 400. For example, plug 621 of integrated port dome 620 may besized and shaped to snugly interlock with, e.g., lip 619 of main chamber612. Integrated port dome 620, like integrated port dome 310, may bemade from a biocompatible material with self-sealing capabilities, suchas silicone.

FIGS. 7A and 7B show three-dimensional views of integrated port assembly600. In particular, FIG. 7A depicts integrated port assembly installedwithin an opening 702 in an implant shell 700. As with integrated portassembly 400 and implant shell 500, the edge of opening 702 in implantshell 700 may be angled in a manner complementary to an angle of step624 of integrated port dome 620, so as to fit snugly against step 624.As show in both FIGS. 7A and 7B, the location of coil 616 is representedwithin coil housing 614 by dashed lines. Integrated port dome 620 may beattached to an outer surface of implant shell 700, so as to form a sealbetween integrated port dome and implant shell 700.

The integrated port assemblies disclosed herein, such as integrated portassemblies 400, 600, may serve as, e.g., refill ports in implants whichneed to be filled and/or refilled, such as tissue expanders. This isdescribed further herein, with respect to FIGS. 10A-10C.

Implants, such as tissue expanders, having integrated port assemblies(e.g., integrated port assemblies 400, 600) may additionally include oneor more electronic components for controlling changes to the implants,such as, e.g., inflation or deflation of a tissue expander via anintegrated port assembly (e.g., integrated port assembly 400, 600). Insome aspects, a tissue expander having an integrated port assembly suchas those disclosed herein may further include means to remotelyfill/inflate the expander via the integrated port assembly.

In some aspects of the present disclosure, inflation and deflation maybe performed automatically according to one or more algorithms orpredetermined parameters, and/or may be controlled by user input, suchas instructions provided via a user interface of a tablet computer orother electronic device in wireless communication with the sensorpackage. In at least one example, inflation/deflation may be controlledaccording to parameters set in a reader and shown in an LED displayoutput of a reader. Readers according to the present disclosure aredescribed in further detail below.

Platform Reader

The present disclosure also includes readers for use with transponders,sensors, and integrated port assemblies disclosed herein. Generally,transponders and integrated port assemblies disclosed herein may becompatible with a variety of commercially available RF readers.Additionally, disclosed herein are readers that may be compatible withmultiple types of transponders and coils, which may be able to sendand/or receive signals at varying degrees of strength and at varyingfrequencies. A platform reader is disclosed herein which, in order todetect a given transponder or coil, may broadcast signals in a sweep offrequencies, receive signals in varying degrees of strength in return,and adjust the broadcast signal to correspond to the strongest receivedsignal in order to best pick up return signals from the giventransponder or coil.

FIG. 8 shows a block diagram of components of an exemplary platformreader 800 according to the present disclosure. Platform reader 800includes a microcontroller 802, which may have one or more USBconnections 804 and displays 806. Platform reader 800 also may includeone or more power supplies 808 connected to microcontroller 802.Microcontroller 802 may control clock generator 810, which may in turncontrol a driver/amplifier 812. Driver/amplifier 812 may be connected toan antenna 814. Antenna 814 may be connected to transformer 816, whichmay in turn be connected to an analog front end 818. An analog todigital converter (ADC) 820 may be connected to analog front end 818 andmicrocontroller 802.

Antenna 814 may also be connected to a logarithmic amplifier 824. Apickup antenna 822 may also be connected to logarithmic amplifier 824.

Microcontroller 802 may be, for example, a small computer on anintegrated circuit, capable of receiving data from a variety ofcomponents, and also capable of directing a variety of components toperform their functions. For example, microcontroller 802 may containone or more computer processing units (CPUs), as well as memory andprogrammable input/output peripherals. Microcontroller 802 may, forexample, receive input and instructions via a digital connection, whichmay, for example, be a USB connection 804. In alternate embodiments, USBconnection 804 may be another type of connection, such as an eSATAconnection, a Firewire connection, an Ethernet connection, or a wirelessconnection. Connection 804 may connect microcontroller 802 to, forexample, an input/output device capable of programming microcontroller802, such as a computer.

Microcontroller 802 may also have a display 806, which may be, forexample, an LED display. Display 806 may be configured to displaycalculations, input, output, and instructions sent and received bymicrocontroller 802. In some embodiments, display 806 may be configuredto display instructions or input received via, e.g., connection 804. Inalternate embodiments, display 806 may simply be a series of displaylights. In further alternate embodiments, display 806 may be a non-LEDdisplay, such as an LCD display or other display.

Platform reader 800 may also include one or more power supplies 808.Power supplies 808 may include any type of power supply compatible withelements of platform reader 800, including, for example, alternatingcurrent power supplies, direct current power supplies, battery powersupplies, etc. In FIG. 8, power supplies 808 are shown as beingconnected to microcontroller 802. However, in further embodiments, powersupplies may additionally or alternately be connected to any othercomponent of platform reader 800.

Microcontroller 802 may be connected to clock generator 810, which mayin turn be connected to driver/amplifier 812. Clock generator 810 may bea circuit that may provide a timed signal having a precise frequencyand/or wavelength, through which microcontroller 802 may instructdriver/amplifier 812 to output a sweep of broadcast signals at a desiredspeed or interval. Driver/amplifier 812 may include, for example, adriver that generates an RF signal, and an electronic amplifier that maygenerate a low-power RF signal and amplify the signal into a higherpower signal. Driver/amplifier 812 may include, for example, any type ofRF driver/amplifier known in the art, such as either a solid state or avacuum tube amplifier.

Driver/amplifier 812 may be connected to antenna 814. Antenna 814 maybe, for example, an RF antenna. Antenna 814 may, on the one hand, beconnected to transformer 816, which is in turn connected to analog frontend 818 and ADC 820. Together, transformer 816, analog front end 818,and ADC 820 may be configured to receive and process signals, e.g.,carrier and modulated signals, from antenna 814 and convert them todigital values, for return to microcontroller 802. In particular,transformer 816 may be configured to transform a received high voltagesignal from antenna 818 and transform it to a voltage that may beprocessed by other elements of reader 800 (e.g., analog front end 818,ADC 820, and/or microcontroller 802) without damaging those otherelements. Analog front end 818 may be configured to filter out portionsof received and transformed signals from transformer 816. For example,analog front end 818 may be configured to process received signals suchthat carrier signals having the same wavelength and/or frequency assignals broadcasted by antenna 814 are removed, leaving only modulatedsignals (e.g., signals modulated by a transponder which received andreturned a signal from antenna 814). ADC 820 may be configured toconvert the filtered modulated signal to a digital value.

Antenna 814 may also be connected to logarithmic amplifier 824, whichmay also be connected to an optional pickup antenna 822. Pickup antenna822 may serve as an additional antenna configured to assist in pickingup weaker signals. Weak signals received by either antenna 814 or pickupantenna 822 may be amplified by logarithmic amplifier 824 and passed toADC 826. Logarithmic amplifier 824 may be an amplifier configured toreceive weak signals and amplify them on a logarithmic scale, such thatthey may be processed by ADC 826 and microcontroller 802. ADC 826 may beconfigured to convert signals received from logarithmic amplifier 824,and provide them to microcontroller 802, which may be configured toassess the strength of signals received from ADC 826. In this manner,platform reader 800 may be able to evaluate and process signals spanninga breadth of signal strength.

In some embodiments of reader 800, microcontroller 802 may be, forexample, connected directly to driver/amplifier 812. In suchembodiments, microcontroller 802 may be configured to provide a signalfrequency and wavelength directly to driver/amplifier 802, withoutgeneration of the signal by clock generator 810.

Elements of reader 800 may be permanently or removably connected to oneanother. For example, antenna 814 and/or pickup antenna 822 may beremovably attached to other elements of reader 800.

FIG. 9 depicts, in block diagram form, steps of a method 900 forbroadcasting a signal having a frequency optimized for a giventransponder. Method 900 may be performed using, for example, platformreader 800. According to step 900, a clock generator may be used tocontinuously provide a signal driver/amplifier with a sweeping range offrequencies. According to step 904, the signal driver/amplifier may beused to continuously broadcast signals having the provided sweepingrange of frequencies via a main antenna. According to step 906, returnedsignals from a transponder within the range of the main antenna may becontinuously monitored for via the main antenna. According to step 908,a determination may be made as to whether any returned signals are weakor nonexistent. If not (i.e., if returned signals are strong), thenaccording to step 910 a transformer may be used to continuouslytransform the returned signals into voltage differences. If so, thenaccording to step 912, a pickup antenna may be used to continuouslymonitor for weaker signals, and according to step 914, a logarithmicamplifier may be used to amplify signals received by the pickup antennaand transform them into voltage differences. According to step 916, ananalog-to-digital converter may be used to continuously convert thevoltage differences (transformed in either step 910 or step 914) todigital values and transmit the digital values to the microcontroller.According to step 918, the microcontroller may be used to determine thehighest received digital signal. According to step 920, themicrocontroller may be used to determine a frequency of the broadcastsignal corresponding to the highest received digital signal. Accordingto step 922, the microcontroller may be used to instruct the clockgenerator to provide the signal driver/amplifier with the determinedfrequency. According to step 924, the signal driver/amplifier broadcastsa signal having the determined frequency.

According to method 900, a clock generator may be used to continuouslyprovide a signal driver/amplifier with a sweeping range of frequencies.For example, with respect to platform reader 800, microcontroller 802may provide clock generator 810 with instructions to provide signaldriver/amplifier 812 with a sweeping range of frequencies. Frequenciesmay range from, e.g., about 80 kHz to about 400 kHz. For example, insome embodiments, frequencies may range, e.g., from about 80 kHz toabout 300 kHz, from about 100 kHz to about 250 kHz, from about 100 kHzto about 200 kHz, from about 110 kHz to about 150 kHz, from about 110kHz to about 140 kHz, or from about 120 kHz to about 150 kHz. In someembodiments, a sweeping range of frequencies may include commonly usedor standardized frequencies, such as, e.g., about 125 kHz and/or 134.2kHz. In some embodiments, a sweeping range of frequencies may span 3 or4 kHz above and below commonly used or standardized frequencies, suchas, e.g., a range of from about 121 kHz to about 129 kHz, or from about130.2 kHz to about 138.2 kHz. In some embodiments, a speed at which thesweeping range of frequencies is provided may depend, for example, onhow large the range of frequencies is, and/or how many times a sweep isrepeated. In some embodiments, for example, a sweeping range offrequencies may be provided for, e.g., less than a second. In otherembodiments, for example, a sweeping range of frequencies may beprovided for, e.g., one or more seconds.

According to step 904, the signal driver/amplifier (e.g.,driver/amplifier 812) may be used to continuously broadcast signalshaving the provided sweeping range of frequencies via a main antenna(e.g., antenna 814). The signal driver/amplifier may be instructed tobegin continuously broadcasting signals by a controller, such as, e.g.,microcontroller 802.

According to step 906, returned signals from a transponder within therange of the main antenna may be continuously monitored for via the mainantenna (e.g., antenna 814). The existence and/or strength of returnedsignals from a transponder within the range of the antenna, such as anRF transponder (e.g., transponder 100, 200), may depend upon, e.g., thefrequencies broadcast in step 904 by, e.g., driver amplifier 812. Atransponder may be configured to return the strongest signal at aparticular frequency, such as, e.g., 125 kHz. Thus, as the signaldriver/amplifier approaches that frequency in its sweeping broadcast,the returned signal from the transponder may increase and peak at thatfrequency.

According to step 908, a determination may be made as to whether anyreturned signals are weak or nonexistent. Such a determination may bemade by, for example, a low signal strength or lack of signals receivedby microcontroller 802, after any received signals have been processedby transformer 816, analog front end 818, and ADC 820. If not (i.e., ifreturned signals are strong), then according to step 910 a transformermay be used to continuously transform the returned signals into voltagedifferences. If so, then according to step 912, a pickup antenna (e.g.,pickup antenna 822) may be used in addition to the main antenna (e.g.,antenna 814) to monitor for weaker signals, and according to step 914, alogarithmic amplifier (e.g., logarithmic amplifier 824) may be used toamplify weak signals received by either the pickup antenna or the mainantenna and transform them into voltage differences that may beconverted by an ADC (e.g., ADC 820 or ADC 826).

In an alternative embodiment, a pickup antenna (e.g., pickup antenna822) may be used in addition to a main antenna to monitor for weakersignals, and a logarithmic amplifier (e.g., logarithmic amplifier 824)may be used to amplify weaker signals received by either the pickupantenna or the main antenna, without first determining whether anyreturned signals are weak or nonexistent.

According to step 916, an analog-to-digital converter may be used tocontinuously convert the voltage differences (transformed in either step910 or step 914) to digital values and transmit the digital values tothe microcontroller. For example, ADC 820 may be used to continuouslyconvert voltage differences transformed by transformer 816, and ADC 826may be used to continuously transform voltage differences amplified bylogarithmic amplifier 824. According to step 918, the microcontroller(e.g., microcontroller 802) may be used to determine the highestreceived digital signal (for example, from the combined pool of digitalsignals received from both ADC 820 and ADC 826).

According to step 920, the microcontroller may be used to determine afrequency of the broadcast signal corresponding to the highest receiveddigital signal. The highest received digital signal may correspond to anoptimal broadcast signal to receive the clearest return from atransponder in the vicinity of one or more antennae (e.g. antenna 814and pickup antenna 822).

According to step 922, the microcontroller may be used to instruct theclock generator to provide the signal driver/amplifier with thedetermined frequency, after which, according to step 924, the signaldriver/amplifier may be instructed to broadcast a signal having thedetermined frequency.

The above-disclosed method thereby provides a manner in which a signalfrequency may be adjusted to suit a particular transponder.Advantageously, this may allow for a reader, such as platform reader800, to broadcast a tailored signal to a transponder which may not beconfigured to respond to an exact standard signal (standard RFID signalsinclude, e.g., 125 kHz and 134 kHz). Because slight differences in,e.g., coil shape, coil size, and number of coil turns may result in atransponder, particularly a relatively small transponder, having anoptimal frequency that is slightly different from a standard frequency,and because a relatively small transponder without a ferromagnetic core(such as, e.g., transponders 100, 200) may already have a limited rangeand signal strength, determining an optimal frequency for a transponderand then reading the transponder at that frequency may result in astronger, improved return signal than would be received with a standardsignal.

Readers, such as platform reader 800, may be used in order to sendinformation to and receive information from transponders disclosedherein, such as, for example, transponders 100, 200, and integrated portassemblies 400, 600. While this disclosure describes platform reader 800in the context of transponders for use in implants, such as breastimplants, it is to be understood that platform reader 800, and methodsof using platform reader 800, such as method 900, may be used in othercontexts as well.

FIGS. 10A-10C depict the use of a reader 1000 to inject fluid into atissue expander 1002 having an integrated port assembly 1004 equippedwith an antenna coil 1006 (shown by dashed lines). As depicted in eachfigure, a patient may have had a tissue expander 1002 surgicallyimplanted in, adjacent to, or in place of, breast tissue 1001. Reader1000, for example, may be or share characteristics with platform reader800. Integrated port assembly 1004 may be or share characteristics with,for example, integrated port assembly 400 or integrated port assembly600. The center of integrated port assembly 1004 may be identified by anelectronic reader looking for the “windowing” or center of the woundantenna coil in each integrated port assembly; e.g., as “a targetingelement,” as described further below.

As depicted in FIG. 10A, a reader 1000 configured to locate antenna coil1006 may be used in order to determine the location of antenna coil1006, and thus integrated port assembly 1004, underneath patient'stissue 1001. Reader 1000 may, for example, have an antenna configured toinduce and detect magnetic fields in nearby electromagnetic coils.Reader 1000 may, for example, output a number on a display 1000,indicating a distance between a point on reader 1000 and a center of acore of antenna coil 1006, and may continuously update the output numberas reader 1000 is moved over patient tissue 1001. Once reader 1000displays a number below a given threshold, or otherwise indicates thatreader 1000 has located the core of antenna coil 1006, then a physicianmay prepare to inject fluid at the designated spot in patient tissue1001.

Once integrated port assembly 1004 has been located, in someembodiments, a mark may be made on the skin of patient tissue 1001 forproper alignment for a fluid injection device with integrated portassembly 1004. In some aspects, reader 1000 may be equipped with aneedle guide 1200 to assist with alignment with integrated port assembly1004. In some aspects of the present disclosure, the needle guide mayinclude a sleeve, which may be sterile and/or disposable so that thereader may be used on multiple patients.

As depicted in FIG. 10B, a fluid injection device 1008 may be used toinject fluid into, and thus expand, tissue expander 1002 throughpatient's tissue 1001 and integrated port assembly 1004. Fluid injectiondevice 1008 may be, for example, a syringe, such as a manual syringe, anautomated syringe, a pipette, or other fluid deposition device. Finally,as depicted in FIG. 10C, once fluid has been injected using fluidinjection device 1008, and once fluid injection device 1008 has beenwithdrawn, tissue expander 1002 may have a larger volume.

Data Analysis and Further Transponder Uses

Multiple combinations of, and uses for, the transponders, sensors, andreaders disclosed herein to achieve different results may be possible.Some of these combinations and uses are expanded upon below.

Data Analysis

The present disclosure also includes algorithms that account forcharacteristics of the physiological environment from which data isbeing collected. The algorithms may be used to assess and/or analyze thedata to provide a translational outcome or output. For example, thealgorithms may incorporate particular characteristics and nuances of thematerials used in the construction of the medical devices. Suchcharacteristics may include, for example, the chemical composition ofthe medical devices and/or surface characteristics (or other physicalcharacteristics, such as the dissolution of drugs or agents from thesurface or rate of degradation of a biodegradable materials). Forexample, the particular chemical composition of silicone used in abreast implant or tissue expander and/or the surface properties of themedical devices may affect their interaction with the patient'ssurrounding tissue. The selection of appropriate materials may be atleast partially based on biocompatibility, the ability to reduce orregulate an appropriate immunological response, and/or the ability to bepartially or completely inert. Non-permeable materials such as glass maybe used to encapsulate sensors and micro-electronics as a suitable typeof inert coating. Additionally, or alternatively, the algorithms mayinclude consideration of the depth and location of the medical deviceswhen implanted (e.g., characteristics of the surrounding tissues) and/orpotential interference from other active (powered) devices such as otherimplants.

As a further example, the algorithms may take into account one or morephysiological parameters such as, e.g. pH, temperature, oxygensaturation, and other parameters, which may aid in the screening,diagnosis and/or prediction of a disease, disorder, or other healthcondition (including, for example, tissue inflammation or infection).These algorithms may be designed to filter through data collected fromthe sensor(s) in order to optimize the ‘signal-to-noise ratio’, andinclude formulations that determine the significance of combinedanalytical data; e.g. pressure, pH and/or temperature in the assessmentof infection or tissue inflammation. Other combinations of data may beindicative of foreign (e.g., cancerous) tissues. The algorithms hereinmay be predictive of structural changes, e.g., by revealing a weakeningin a portion of the medical device before failure. For example, thealgorithm may identify a weakening in the shell of a breast implantbefore it ruptures and/or sense a rupture or tear in the shell based on,for example, a change in pressure.

In some aspects, the algorithms may take into account individualizedpatient data. For example, the algorithms may collectively analyzevarious data, both data collected from the sensor(s) integrated into amedical device implanted into a patient and data specific to thatindividual patient. For example, a sensor that collects pH, pressure,and temperature may provide clinical data more meaningful in somerespects if the algorithm contemplates other physiological data (suchas, e.g., blood parameters, genomics, tissue elasticity, and/or otherhealth parameters).

Data analysis according to the present disclosure may includeanti-collision technologies for low frequency systems, e.g., having theability to read data from multiple sensors at the same time.Transponders that comprise an RF antenna generally have the ability totransmit and receive data. Communication of data may include specificASIC programming, which may depend on the frequency of RF signals.Therefore, each transponder may selectively communicate with one or moreother sensors in sufficient proximity, which may include transpondersimplanted elsewhere in the patient.

Medical Device Information

Device Breach/Failure: pH Change

According to some aspects of the present disclosure, the transpondersdisclosed herein may provide information on the status of the implantedmedical device, when used in combination with various types of sensors.For example, pH sensors may be used to detect a breach of interstitialfluid such as blood and/or proteins that may infiltrate a failingmedical implant. Such pH sensors may be positioned at various locationsaround the surface of the medical device. For example, one or more pHsensors may be coupled to, or embedded in, the surface of a breastimplant or tissue expander. Multiple sensors, coupled with transponders,may be in communication with one another via frequency linking, e.g., adhoc or hard wired. A change in pH may be detected by the sensor(s) incase of a breach of the medical device. For a breast implant, forexample, a change in pH may result from a breach in the outer shellwall, or a breach in a portion of the shell with permeable access to thesounding tissue. Some medical devices according to the presentdisclosure may include a conduit that allows passive flow (e.g.,convection or conduction) of external interstitial fluid to the sensorresiding deeper inside the medical device, such that a bodily fluid suchas blood may diffuse into the medical device due to a breach and bedetected by the sensor.

Device Failure: Other Detection Methods

According to some aspects of the present disclosure, an implantablemedical device may include a meshed nanoscale detection system usingfluid chemistry, chemical, electronic or mechanical substrate materialsto detect a breach in the implantable medical device, such as a shellbreach. Additionally, or alternatively, the medical device may includeexternal and/or internal systems using infrared (IR) or low wave light(or low wave electronic field) for examining breach detection with chipenhancers within the medical device. This type of system may help detecta disruption in a continuum, such as a break in a wavelength orelectromagnetic field from an interference caused by a mechanicalrupture in the medical device. In this type of system, for example, achip enhancer may use the full duplex system of coupling to look for aparticular antenna's highest (strongest) resonant frequency (highest Q)and adjust to read data at that level. The search for the highest Q maybe performed with specialized crystals within a range and a kernelplaced in the firmware of a reader (e.g., reader 800).

As an example, an implantable medical device may include an intactelectroconductive barrier as one shell component of the implantablemedical device, such that breach of a shell of the implantable medicaldevice, including the electroconductive barrier, may cause a change inelectrical resistance of the electroconductive barrier. The implantablemedical device may further include a transponder (e.g., transponders100, 200) within a space enclosed by the electroconductive barrier(e.g., within the implant). Such a transponder may be, for example, anRF transponder, as has been previously disclosed herein. In someembodiments, such a transponder may be configured to receive power viainduction by, e.g., an external reader, as has been previously describedherein. In further embodiments, such a transponder may be provided withan independent power source, such as a battery. A breach in theelectroconductive barrier may cause a change in the ability of anexternal reader (e.g., reader 800) to send transmissions to and/orreceive transmissions from the transponder within the space enclosed bythe electroconductive barrier. Thus, the presence of, and changes in,the electroconductive barrier may assist in determining whether a partof an implantable medical device (e.g., a shell) is intact, or has beenbreached or otherwise damaged.

FIG. 11 depicts an example of a portion of an implant shell which maycontain an electroconductive barrier layer. An implant having amultilayered shell 1100 may be modified to include an electroconductivelayer 1106 in between an inner layer 1104 of shell 1100 and an outerlayer 1102 of shell 1100. Electroconductive layer 1106 may be configuredto resist, block, reduce, interfere with, or impede transmission ofsignals, such as RF signals, across the shell 1100 of the implantablemedical device, as long as the electroconductive layer remains intact.

Inner layer 1104 and outer layer 1106 of shell 1100 may be made of anysuitable biocompatible material. In some embodiments, inner layer 1104and outer layer 1106 may be made of non-electroconductive materials. Forexample, one or more of inner layer 1104 and outer layer 1106 may bemade of silicone, or plastic, such as PEEK.

Electroconductive layer 1106 may be made of any biocompatible materialthat blocks, reduces, interferes with, or impedes transmission of RFsignals across the layer. For example, in some embodiments,electroconductive layer 1106 may be a layer of carbon. Electroconductivelayer 1106 may be, for example, a solid layer, or may be a layer havinga regular or irregular mesh pattern (e.g., resembling a cage or a net).In embodiments where the electroconductive layer 1106 has a meshpattern, any gaps in the mesh pattern may be sufficiently small toprevent signals from being received by or transmitted from a transponderenclosed by electroconductive layer 1106. In some embodiments,electroconductive layer 1106 may be, or may be similar to, a Faradaycage or enclosure.

In some embodiments, electroconductive layer 1106 may be, for example,between inner layer 1104 and outer layer 1102 of implant shell 1100. Infurther embodiments, electroconductive layer 1106 may be, for example,an innermost layer of an implant shell 1100. In yet further embodiments,electroconductive layer 1106 may be, for example, an outermost layer ofan implant shell 1100. In some embodiments, implant shell 1100 may havemultiple inner layers 1104, multiple outer layers 1102, and/or multipleelectroconductive layers 1106.

Integrity of electroconducitve layer 1106 (and thus, of a component ofthe implantable medical device, such as a shell component) may betested, for example, by an external reader, such as reader 800, whichmay be configured to send transmissions to, and/or receive transmissionsfrom, a transponder enclosed by electroconductive layer 1106 (e.g.transponders 100, 200). As has been previously described herein, thereader (e.g., reader 800) may be configured to determine and broadcast asignal at a frequency calibrated specifically for the transponder. Ifelectroconductive layer 1106 is intact (e.g., if it has not beenbreached, damaged, or subject to manufacturing defect), then the readermay receive no signal, or a faint or low signal, from the transponderenclosed by electroconductive layer 1106. If electroconductive layer1106 is not intact, then the reader may receive a stronger signal fromthe transponder enclosed within electroconductive layer 1106, due to thebarrier function of electroconductive layer 1106 being disrupted. Thus,electroconductive layer 1106 may assist in determining whether animplantable medical device is defective.

In some examples, electroconductive layer 1106 may have a color, suchthat it may be visually inspected for defects, imperfections, orbreaches. The color may, in some embodiments, render electroconductivelayer 1106 opaque or semi-opaque. For example, electroconductive layer1106 may be black, or may be blue, green, pink, red, white, or any othercolor.

In further examples, a reader may provide an ASIC with power to probethe barrier for a change using an electromagnetic sensor. Similartechniques may be used with electrically conductive nanocomponents ornanomaterial. For example, electrically conductive nanomaterials may besprinkled within individual mono layers of a shell (e.g., providing awire like substrate), which, if broken or disrupted, may cause a changein resistance. In yet another example, a small low energy light sourcemay be placed within the medical device, and when powered, the light mayshine and reflect off a material coating the inner layer of the shell.But if breached or broken, the light may not reflect, providing for achange detected by the reader and calculated against the parameters ofthe initial calibration.

Advantageously, such electroconductive layers and reflective coatinglayers may be used to determine whether an implantable medical devicehas been breached, broken, or has a manufacturing defect both before andafter implantation. In particular, such layers may assist innoninvasively determining whether an implantable medical device (e.g., abreast implant) is or has become defective. In some embodiments, areader as disclosed herein (e.g., reader 800) may be used, inconjunction with an implant having a layer such as the layers describedabove, by, e.g., a doctor, a nurse, a patient, or another individualassociated with either the implantable medical device or the patient todetermine whether the implantable medical device is or has becomedefective. Thus, advantageously, such layers may also assist in allowingfor noninvasive examining/analysis of, e.g., structural integrity of animplantable medical device by a variety of individuals.

Device Position/Orientation

In addition to information about the failure of a medical device, thetransponders disclosed herein (e.g., transponders 100, 200) may be usedto determine whether the medical device maintains its appropriateimplanted position and orientation. After implantation, for example, amedical device may migrate over time from its proper position. Sensors,coupled with transponders according to the present disclosure, maymeasure and project data indicative of cyclo-rotation, vibrational,torsional or misalignment (e.g., movement) of an implanted medicaldevice. Such sensors may capture the number of cycles an articulatingsurface may be exposed to (i.e. a knee or hip implant, annulus of aheart valve, or frequency of changes in pressure gradients in a shunt orvascular graft). The sensors may include elements such as a gyro, a typeof accelerometer, which may measure changes in angulation and/or angularvelocity. Other suitable sensors include fiber-optic rotational sensors,which may comprise an active light source and reader. An inertialmeasurement unit (IMU) may be used to combine information from two ormore sensors, such as gyros, 3-D accelerometers, magnetometers, and/orGPS units to determine information such as device orientation andvelocity vector. In some aspects, a combination of sensors may be usedto determine comprehensive status information on a medical device.

In some aspects, the sensor(s), coupled with transponders of the presentdisclosure, may measure the change of orientation of radiopaque markersin relationship to one or more anatomical features or landmarks. Forexample, a patient may undergo periodic X-rays to assess location andorientation information. In such cases, a sensor configured fordosimetry measurements may be used.

Data Transmission

Data about an implantable medical device may be transmitted and receivedconstantly, periodically, on demand (in response to user inquiry), orwhen certain values or parameters are detected. In some examples, atransponder may include a dual-processor ASIC approach, wherein aspecific ASIC may be used for medical management of a transponder (e.g.,to determine when the sensor actively “reads” or “sleeps”), and theother ASIC may be used for power management (e.g., to regulate how muchenergy is provided to the system). The power management ASIC may includean algorithm to maintain an appropriate level of charge, e.g., avoidcomplete discharge.

The method and/or frequency of data transmission may depend on therelevance of the data to the patient or given medical context. Forexample, for more serious conditions or events such as a device rupture,a transponder coupled with a particular sensor or sensors configured todetect rupture may also be configured to push the data to an externaldevice, such a mobile device or other electronic device. This type ofdata transmission may be incorporated into an algorithm and used as partof an active system. Further, for example, data indicative of tissueinflammation or inappropriate rotation/placement of the medical devicemay be transmitted on demand by sending a wireless signal from theexternal device periodically (e.g., on a weekly, biweekly, or monthlybasis). On-demand transmission of data may be initiated, for example,when the patient is reminded from an uploaded app on a mobile device. Atransponder configured for constant or nearly constant transmission ofdata may include a power source or recharging element sufficient tomaintain power over an extended period of time.

Lab-On-a-Chip

The transponders disclosed herein, combined with sensors disclosedherein, may be configured as a lab-on-a-chip, e.g., a subset ofmicroelectromechanical systems (MEMS) that may employ microfluidics tocapture and identify and/or quantify biomarkers, e.g., for proteomics.Such micro analytic systems may use Surface Plasmon Resonance (SPR) andrelated systems and techniques to detect a wide variety of biomolecularinteractions that otherwise may have low spectroscopic signals orreaction heats. These systems may provide data analytics to optimizetherapeutic devices and treatments related to binding affinities ofantibodies, drug/cellular membrane absorption rates, and/or tissuesensitivity levels that may impact the dosage (dosimetry) ofchemotherapy or radiation therapies. Such lab-on-a-chip sensor andtransponder combinations may comprise a suitable power source. Thesetypes of sensor and transponder combinations may be useful as anassessment tool, e.g., to determine if a particular patient wouldrespond better to adjunctive substrates such as hyaluronic acid orchitosan.

Data Output

The present disclosure further includes means to optimize the dataoutput for readers, including the range and sophistication to decodespecific algorithms. Data may be encoded for patient confidentiality, incompliance with HIPPA regulations. Data may be accessible by a mobiledevice such as a smartphone or tablet computer, e.g., via password- orfingerprint-protected access.

The transponders disclosed herein may communicate on specificradiofrequencies, e.g., to optimize the inductive recharging of anactive sensor. For example, the RF antenna may function as a receiverfor inductive energy to recharge embedded power cells. Such range offrequencies may be utilized so that the sensors do not interfere withother communication frequencies or cause heating of components orcoatings of the sensors or heating of surrounding patient tissues.Exemplary ranges include, for example, from about 80 kHz to about 400kHz, such as from about 80 kHz to about 350 kHz, from about 80 kHz toabout 320 kHz, from about 100 kHz to about 300 kHz, from about 100 kHzto about 250 kHz, from about 100 kHz to about 200 kHz, from about 100kHz to about 180 kHz, from about 100 kHz to about 150 kHz, from about100 kHz to about 140 kHz, from about 110 kHz to about 140 kHz, fromabout 120 kHz to about 140 kHz, or from about 125 kHz to about 135 kHz.Reference may be made to ISO standards 11784/85.

The transponders disclosed herein may include one or more ASICs thatprovide for storage and appropriate power management that utilizes athreshold of self-containment so that the system does not completelydischarge, which may lead to explantation. A self-contained system isgenerally configured to regulate itself, and prevent a total discharge.For example, the ASICs herein may place the power source in hibernationonce the power level reaches a given threshold, therefore allowing forrecharging rather than becoming a totally “dead” battery.

Security

The transponders, readers, implants, and port assemblies disclosedherein may be incorporated into a security system for, e.g., cloud dataaccess. Such a security system may provide for push opportunities(alerts) to user devices, such as, e.g., the readers disclosed herein,or other secured personal devices such as tablets, computers,smartphones, mobile devices, etc. Such a security system may therebyprovide for tracking of transponders, implants, and implant parts frommanufacturer to surgeon; and possibly from surgeon to patient. Devicesused to receive and transmit information between the medical device,computer/mobile device, and cloud/Internet server may include, but arenot limited to, an RF reader with WIFI connectivity, and Bluetoothconnectivity to an electronic device connected to the Internet.According to some aspects, manufacturers, physicians, and/or patientsmay interact with such a security system through an RF reader and/or anapp on a mobile electronic device.

While the figures and disclosure herein depict several exemplaryconfigurations of transponders, sensors, assemblies, readers, implants,and several exemplary methods of use thereof, one of ordinary skill inthe art will understand that many other configurations and variations onmethods are possible and may be appropriate for a given implant,patient, procedure, or application, based on implant size, shape,orientation and intended location in the patient body. The examples ofdevices, systems, and methods herein are intended to be exemplary andare not comprehensive; one of ordinary skill in the art will alsounderstand that some variations on the disclosed devices, systems, andmethods herein are also contemplated within this disclosure.

1-60. (canceled)
 61. A tissue expander comprising: a shell defining anexpandable cavity; and a port coupled to the shell to permitintroduction and removal of a fluid from the cavity, the port includinga targeting element; wherein the tissue expander is MM compatible; andwherein the targeting element of the port is configured to generate asignal for noninvasive detection of the port by an external reader. 62.The tissue expander of claim 61, wherein the targeting element isconfigured to passively generate the signal and transmit the generatedsignal to the reader over a distance of at least 4 inches and up to 7feet.
 63. The tissue expander of claim 61, wherein the targeting elementincludes an electromagnetic coil comprising a non-ferromagneticmaterial.
 64. The tissue expander of claim 61, wherein the portcomprises an integrated circuit chip programmed with identifying data ofthe tissue expander.
 65. The tissue expander of claim 61, wherein thetissue expander includes a light source.
 66. The tissue expander ofclaim 65, wherein the light source reflects light off of the shell whenthe light source is powered.
 67. The tissue expander of claim 61,wherein the port includes a first chamber configured to receive thefluid and a second chamber that includes one or more electroniccomponents of the port.
 68. The tissue expander of claim 67, wherein thefirst chamber includes a valve assembly.
 69. The tissue expander ofclaim 67, wherein the second chamber is impermeable to fluids.
 70. Thetissue expander of claim 67, wherein the second chamber contains thetargeting element.
 71. The tissue expander of claim 61, wherein thetargeting element comprises an electromagnetic coil and the portcomprises a dome coupled to the shell, the dome being aligned with acentral axis of the electromagnetic coil.
 72. The tissue expander ofclaim 71, wherein the port comprises a needle stop parallel to the domeand a plurality of fluid holes in communication with the cavity.
 73. Atissue expander comprising: a shell defining an expandable cavity; and aport that permits introduction and removal of a fluid from the cavity,the port comprising: a first chamber configured to receive the fluid;and a second chamber impermeable to fluids; wherein the tissue expanderis MM compatible.
 74. The tissue expander of claim 73, wherein thesecond chamber shares a wall with the first chamber, the wall includinga needle stop.
 75. The tissue expander of claim 73, wherein the secondchamber contains a targeting element that comprises an electromagneticcoil, an integrated circuit chip, or both an electromagnetic coil and anintegrated circuit chip.
 76. The tissue expander of claim 73, whereinthe tissue expander is configured for noninvasive detection of the portby an external reader.
 77. The tissue expander of claim 73, wherein theport comprises a dome coupled to the shell and a needle stop, the domebeing parallel to the needle stop.
 78. The tissue expander of claim 77,wherein the port comprises a plurality of fluid holes, each fluid holeextending in a direction transverse to the needle stop.
 79. A tissueexpander comprising: a shell defining an expandable cavity; and a portcoupled to the shell to permit introduction and removal of a fluid fromthe cavity, the port comprising an electromagnetic coil; wherein thetissue expander is configured for noninvasive detection of the port byan external reader; and wherein the tissue expander is MM compatible.80. The tissue expander of claim 79, wherein the port includes a firstchamber configured to receive the fluid and a second chamber thatcontains the electromagnetic coil.
 81. The tissue expander of claim 80,wherein the second chamber contains an integrated circuit chipprogrammed with identifying data of the tissue expander, the integratedcircuit chip being coupled to the coil.
 82. A tissue expandercomprising: a shell defining an expandable cavity; and a port thatpermits introduction and removal of a fluid from the cavity, the portcomprising: a first chamber configured to receive the fluid; and asecond chamber impermeable to fluids, the second chamber sharing a wallwith the first chamber; wherein the tissue expander is configured fornoninvasive detection of the port.
 83. The tissue expander of claim 82,wherein the tissue expander does not include ferromagnetic materials.84. The tissue expander of claim 82, wherein the tissue expander is MMcompatible.
 85. The tissue expander of claim 82, wherein the tissueexpander is a breast tissue expander.
 86. The tissue expander of claim82, wherein the wall includes a needle stop comprisingpoly-ether-ether-ketone.
 87. The tissue expander of claim 86, whereinthe port comprises at least three fluid holes spaced apart at equalintervals, each fluid hole extending in a direction transverse to theneedle stop.
 88. The tissue expander of claim 82, wherein the secondchamber contains a targeting element aligned with the first chamber, thetargeting element being configured to generate a signal for noninvasivedetection of the port by an external reader.
 89. The tissue expander ofclaim 82, wherein the tissue expander includes a light source thatreflects light off of the shell when the light source is powered. 90.The tissue expander of claim 82, wherein the port comprises a domecoupled to an inner surface or an outer surface of the shell, the domebeing penetrable by a needle and self-sealing upon removal of theneedle.